Director Regulatory Affairs
Title: Director Regulatory Affairs A small sized diagnostics company is seeking a Director of Regulatory Affairs to lead the regulatory submissions, strategy, and maintenance activities for their existing products and new products in development. They are pioneering the field with innovative machine learning-based liquid biopsy mRNA expression tests, designed for both standard-of-care and pharmaceutical trials. These products are patented and unique to the cancer diagnostics market. This role reports directly into the CEO/CSO. Responsibilities: Register two prospective studies with the FDA Serve as the point of contact for submissions to all notified bodies Manage all communications, meeting scheduling, meeting materials and meeting minutes with the FDA and other agencies including requests for meetings, advice, etc. Draft and formulate pre-sub and submission packages/dossiers, which include technical documents and data, e.g. assay validation protocols and reports, clinical reports/data and/or other development documentation. Develop, draft and author regulatory submission documentation, including traditional 510K, de-novo 510K, SRDs, IDEs, and PMAs. Develop regulatory strategies alongside the CSO Act as the lead Regulatory personnel represent Qualifications: 6+ years of experience in IVD Regulatory Affairs Preferred experienced with LDTs Ideally experienced with oncology molecular tests, e.g. NGS, multiplex PCR, etc. Successfully authored and files 510k, de-novo 510/PMA, BTD submissions Hands on experience coordinating FDA procedures: planning FDA meetings, leading FDA meetings, taking notes for FDA meetings, etc. International IVD experience Robust understanding of LDT under CLIA/CAP, NYSDOH, and the FDA LDT Final Rule released May 2024.
US$160000 - US$200000 per annum
Connecticut
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Vice President Regulatory Affairs
Title: Vice President Regulatory Affairs An exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to have a hands on role in guiding the regulatory strategy for cutting edge therapies in the rare disease space. Responsibilities: Collaborate with cross-functional teams, including clinical, commercial, and medical affairs, to develop and implement global regulatory affairs strategies across a product portfolio. Oversee the development and continuous refinement of regulatory policies, procedures, and standard operating procedures (SOPs). Partner with commercial, clinical development, and medical affairs teams to design and implement launch strategies, tactics, and lifecycle management plans. Conduct regulatory assessments to identify product opportunities, risks, and potential challenges. Provide regulatory expertise in the development and approval of promotional materials and marketing campaigns. Work closely with legal, commercial, and clinical teams to develop and review product labeling, advertising, and promotional materials to ensure compliance with regulations. Lead, mentor, and manage the regulatory affairs team, fostering a culture of compliance and high performance. Develop and enhance organizational policies and procedures for regulatory affairs and compliance. Anticipate global regulatory changes and proactively adapt strategies to address them. Provide strategic guidance on all aspects of regulatory requirements in drug development. Interpret communications and decisions from regulatory bodies such as the FDA and international health authorities, developing strategies to resolve issues effectively. Draft, review, and submit responses and documentation to regulatory agencies, ensuring compliance with submission requirements. Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and follow-up actions. Design innovative regulatory strategies for label enhancements and lifecycle product management. Advise senior management on the status of global regulatory strategies, tactics, and risk assessments related to regulatory filings. Review and approve external communications, advertising, and promotional labeling to ensure compliance with corporate policies and applicable laws. Oversee project planning, ensuring priorities are set and key milestones are met in a timely manner. Manage collaborations with contract research organizations (CROs) or external partners, ensuring global submissions align with regulatory requirements. Maintain up-to-date knowledge of the global regulatory landscape, competitive trends, and regulatory guidelines. Establish and direct global benefit-risk strategies for products at all stages of development, including pre-market, post-market, and lifecycle management. Perform other duties as necessary, depending on organizational needs. Qualifications Bachelor's degree in a scientific discipline (advanced degree such as Ph.D. or PharmD preferred) 15+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industries Must have experience in the rare disease space Demonstrated ability to design and implement regulatory strategies for innovative products. In-depth understanding of FDA regulations, ICH guidelines, and the drug development process. Experience preparing regulatory submissions, including INDs and clinical trial documents. Prior experience with clinical trials and regulatory documentation is required. Experience with inhalation products, biologics, or related areas is preferred. Comfortable working in a fast-paced, high-visibility environment with evolving priorities. Willingness to travel up to 15%
US$290000 - US$365000 per annum
Boston
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Director Regulatory Affairs
Director of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development. Key Responsibilities: Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence. Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts. Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities. Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents. Support due diligence activities for potential product acquisitions or partnerships. Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings. Monitor the regulatory landscape and communicate updates to stakeholders. Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues. Qualifications: Bachelor's degree in life sciences or related field; advanced degree preferred. Minimum 10 years of experience in pharmaceutical regulatory drug development. Proven track record in new chemical entity and line extension filings. Experience interacting with global health authorities and conducting due diligence. Strong knowledge of global pharmaceutical regulations and excellent communication skills.
Up to US$225000 per annum
Philadelphia
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Senior Regulatory Affairs Quality Systems Specialist
Title: Senior Regulatory Affairs and Quality Systems Specialist The Regulatory Affairs and Quality Systems Specialist is responsible for supporting regulatory and quality assurance processes related to in vitro diagnostic (IVD) medical devices. This organization offers a dynamic and collaborative work environment where you have the opportunity to make a meaningful impact in the field of medical diagnostics. With a focus on innovation and excellence, this company provides ample opportunities for professional growth and development, supporting career advancement through hands-on experience and cross-functional collaboration. You will be empowered to contribute to projects that improve healthcare outcomes globally, particularly in the realm of in vitro diagnostic devices. Key Responsibilities Project Compliance and Oversight: Attend project meetings to ensure all medical device design, development, and manufacturing activities meet regulatory requirements, including U.S. FDA's QSR (21 CFR Part 820), ISO 13485, and other relevant standards. Regulatory Strategy Support: Collaborate with internal teams and external partners to develop and implement a global regulatory strategy to meet U.S. FDA requirements and support business goals. Quality System Management: Assist in the management of the organization's Quality System in relation to bringing medical device products to market, including document control and regulatory compliance. Regulatory Submissions: Provide guidance and support in the drafting and submission of regulatory filings, with a particular focus on FDA Q-Submissions and premarket notifications. Clinical and Validation Support: Assist in the preparation and review of technical documents, protocols, and data for clinical trials, validation, verification, and product manufacturing. Regulatory Documentation Management: Maintain regulatory files and databases to ensure accuracy and continuity of information across various platforms. Process Improvement and SOPs: Draft and update Standard Operating Procedures (SOPs) to ensure they reflect current regulatory practices and requirements. Post-market Activities: Manage adverse event reporting, medical device recalls, and product corrections/removals. Product Labeling Oversight: Ensure that product labeling, including Instructions for Use (IFU), complies with all applicable regulatory requirements. Risk Management and Lifecycle Support: Contribute to risk management activities and assist in monitoring product lifecycle changes. Third-Party Audits: Participate in internal and supplier audits, ensuring compliance with regulatory standards and quality system requirements. Qualifications Language Skills: Fluency in English (written and verbal) and Korean (written and verbal) is a Must Bachelor's degree in Engineering, Biology, Biochemistry, Microbiology, or a related field. 5-6 years of experience in a regulated industry, particularly in medical device quality assurance, regulatory affairs, or quality systems management. Experience with FDA and ISO 13485 regulations, including knowledge of IVD medical device regulations, risk management, and design controls. Regulatory Expertise: In-depth knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant standards for medical device manufacturing. Problem Solving and Adaptability: Ability to adjust strategies and plans as business needs evolve. Stakeholder Communication: Strong interpersonal and communication skills to influence and align stakeholders across the organization. Leadership and Organization: Demonstrated leadership ability and project management skills in fast-paced environments. Technical Writing: Ability to draft and review complex technical documentation, regulatory submissions, and SOPs. Attention to Detail: High level of accuracy in data management and documentation. Time Management: Ability to prioritize multiple projects and meet deadlines in a dynamic environment. Public Speaking and Training: Experience speaking in large group settings and training teams on regulatory and quality requirements. Software Skills: Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) is required. Travel Requirements: Must be willing to travel to US and international based offices
US$90000 - US$120000 per annum
Cincinnati
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Associate Director Regulatory Affairs
Title: Associate Director Regulatory Affairs A small but growing clinical stage company is seeking an Associate Director Regulatory Affairs to join the team in a remote capacity. They are seeking a well-rounded RA professional to lead the Regulatory Strategy for their pipeline of phase III products in the rare disease space. Responsibilites: Serves as regulatory affairs representative to provide input on global clinical trials, including coordination of health authority requests, filing activities, and ensuring that documentation and reporting systems are maintained and compliant. Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions. Contributes to the strategy for US FDA interactions with the cross-functional team, including development of content, format, and accountability for regulatory submissions and related supplements and amendments, such as FDA meeting requests, briefing books, meeting minutes, orphan drug annual reports, and DSURs. Supports maintenance and organization of regulatory documentation in partnership with regulatory operations and other teams. Supports US labeling development for NDA. Delivers regulatory achievements for assigned project(s), including the assessment of risks with mitigation strategies, emerging data, and the probability of regulatory success. Develops collaborative and effective relationships across key internal and external partners (e.g., regulatory CMC, regulatory operations, CROs/vendors) to enable rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support and documents in support of global regulatory submissions, health authority meetings and requests, and securing approvals. Leads cross-functional teams, in partnership with global regulatory lead, to develop and execute regulatory strategies for assigned projects and programs. Requirements/Key Attributes: Master's or above degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology, or comparable preferred; bachelor's degree in a scientific field required. 8+ years' experience in drug development, 5+ years in regulatory affairs, rare disease experience preferred. Experience as direct contact with Major Health Authority desired. Previous experience in developing materials, attending, and supporting team preparation for Major Health Authority interactions. Strong experience with CTD format and content of regulatory filings for INDs, NDA/BLAs, MAAs, including developing strategy, writing, and reviewing documents. Strong organizational skills, ability to multi-task and manage workload independently. Detailed knowledge of regulatory drug development including product approval and maintenance. Ability to think strategically and critically evaluate risks to regulatory activities. Ability to work strategically within a business-critical and high-profile development program. Excellent verbal and written communication and presentation skills (English). Strong team player and ability to work across functions (matrix regulatory team). Comfortable in a small company environment that is fast-paced, challenging, and where all leaders must take a hands-on approach to get results. Excited and driven by science and the vision to improve disease management and patient care.
US$160000 - US$190000 per annum
Boston
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Regulatory Affairs Manager
Title: Regulatory Affairs Manager Summary: A development-stage biopharmaceutical company, dedicated to improving patient access to essential therapies and developing innovative treatments for serious diseases is looking to bring on a Manager of Regulatory Affairs to join their team! This company is growing rapidly and they are looking for someone to provide their expertise in generic drugs, ANDA submissions, and regulatory affairs CMC based out of their office in the greater Miami area. This role will give you a great opportunity to contribute to the company's mission to develop treatment options for diseases where therapeutic options are inadequate. The Manager will be responsible forโฆ Formulating and executing regulatory strategies for the development of generic products, product modifications, and life cycle management Actively engaging in the preparation, submission, and management of regulatory filings, with a primary focus on ANDA submissions to the FDA Contributing to and supervise the preparation of dossiers with external vendors, ensuring compliance with regulatory standards and guidelines Collaborating with cross-functional teams to compile and review submission materials Working closely with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are incorporated into product development and life cycle processes The Manager should have the following qualifications: Bachelor's degree in a scientific discipline; advanced degree (MS, PhD) preferred 4+ years of Regulatory Affairs experience in pharmaceutical industry Vast experience with regulatory submissions, especially ANDA submissions Strong interpersonal, leadership, and communication skills Thrives in fast-paced, hands-on environments
Negotiable
Florida
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Vice President Regulatory Affairs
Title: Vice President Regulatory Affairs An exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to have a hands on role in guiding the regulatory strategy for cutting edge therapies in the rare disease space. Responsibilities: Collaborate with cross-functional teams, including clinical, commercial, and medical affairs, to develop and implement global regulatory affairs strategies across a product portfolio. Oversee the development and continuous refinement of regulatory policies, procedures, and standard operating procedures (SOPs). Partner with commercial, clinical development, and medical affairs teams to design and implement launch strategies, tactics, and lifecycle management plans. Conduct regulatory assessments to identify product opportunities, risks, and potential challenges. Provide regulatory expertise in the development and approval of promotional materials and marketing campaigns. Work closely with legal, commercial, and clinical teams to develop and review product labeling, advertising, and promotional materials to ensure compliance with regulations. Lead, mentor, and manage the regulatory affairs team, fostering a culture of compliance and high performance. Develop and enhance organizational policies and procedures for regulatory affairs and compliance. Anticipate global regulatory changes and proactively adapt strategies to address them. Provide strategic guidance on all aspects of regulatory requirements in drug development. Interpret communications and decisions from regulatory bodies such as the FDA and international health authorities, developing strategies to resolve issues effectively. Draft, review, and submit responses and documentation to regulatory agencies, ensuring compliance with submission requirements. Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and follow-up actions. Design innovative regulatory strategies for label enhancements and lifecycle product management. Advise senior management on the status of global regulatory strategies, tactics, and risk assessments related to regulatory filings. Review and approve external communications, advertising, and promotional labeling to ensure compliance with corporate policies and applicable laws. Oversee project planning, ensuring priorities are set and key milestones are met in a timely manner. Manage collaborations with contract research organizations (CROs) or external partners, ensuring global submissions align with regulatory requirements. Maintain up-to-date knowledge of the global regulatory landscape, competitive trends, and regulatory guidelines. Establish and direct global benefit-risk strategies for products at all stages of development, including pre-market, post-market, and lifecycle management. Perform other duties as necessary, depending on organizational needs. Qualifications Bachelor's degree in a scientific discipline (advanced degree such as Ph.D. or PharmD preferred) 15+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industries Must have experience in the rare disease space Demonstrated ability to design and implement regulatory strategies for innovative products. In-depth understanding of FDA regulations, ICH guidelines, and the drug development process. Experience preparing regulatory submissions, including INDs and clinical trial documents. Prior experience with clinical trials and regulatory documentation is required. Experience with inhalation products, biologics, or related areas is preferred. Comfortable working in a fast-paced, high-visibility environment with evolving priorities. Willingness to travel up to 15%
US$290000 - US$365000 per annum
Boston
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Senior Regulatory Affairs Quality Systems Specialist
Title: Senior Regulatory Affairs and Quality Systems Specialist The Regulatory Affairs and Quality Systems Specialist is responsible for supporting regulatory and quality assurance processes related to in vitro diagnostic (IVD) medical devices. This organization offers a dynamic and collaborative work environment where you have the opportunity to make a meaningful impact in the field of medical diagnostics. With a focus on innovation and excellence, this company provides ample opportunities for professional growth and development, supporting career advancement through hands-on experience and cross-functional collaboration. You will be empowered to contribute to projects that improve healthcare outcomes globally, particularly in the realm of in vitro diagnostic devices. Key Responsibilities Project Compliance and Oversight: Attend project meetings to ensure all medical device design, development, and manufacturing activities meet regulatory requirements, including U.S. FDA's QSR (21 CFR Part 820), ISO 13485, and other relevant standards. Regulatory Strategy Support: Collaborate with internal teams and external partners to develop and implement a global regulatory strategy to meet U.S. FDA requirements and support business goals. Quality System Management: Assist in the management of the organization's Quality System in relation to bringing medical device products to market, including document control and regulatory compliance. Regulatory Submissions: Provide guidance and support in the drafting and submission of regulatory filings, with a particular focus on FDA Q-Submissions and premarket notifications. Clinical and Validation Support: Assist in the preparation and review of technical documents, protocols, and data for clinical trials, validation, verification, and product manufacturing. Regulatory Documentation Management: Maintain regulatory files and databases to ensure accuracy and continuity of information across various platforms. Process Improvement and SOPs: Draft and update Standard Operating Procedures (SOPs) to ensure they reflect current regulatory practices and requirements. Post-market Activities: Manage adverse event reporting, medical device recalls, and product corrections/removals. Product Labeling Oversight: Ensure that product labeling, including Instructions for Use (IFU), complies with all applicable regulatory requirements. Risk Management and Lifecycle Support: Contribute to risk management activities and assist in monitoring product lifecycle changes. Third-Party Audits: Participate in internal and supplier audits, ensuring compliance with regulatory standards and quality system requirements. Qualifications Language Skills: Fluency in English (written and verbal) and Korean (written and verbal) is a Must Bachelor's degree in Engineering, Biology, Biochemistry, Microbiology, or a related field. 5-6 years of experience in a regulated industry, particularly in medical device quality assurance, regulatory affairs, or quality systems management. Experience with FDA and ISO 13485 regulations, including knowledge of IVD medical device regulations, risk management, and design controls. Regulatory Expertise: In-depth knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant standards for medical device manufacturing. Problem Solving and Adaptability: Ability to adjust strategies and plans as business needs evolve. Stakeholder Communication: Strong interpersonal and communication skills to influence and align stakeholders across the organization. Leadership and Organization: Demonstrated leadership ability and project management skills in fast-paced environments. Technical Writing: Ability to draft and review complex technical documentation, regulatory submissions, and SOPs. Attention to Detail: High level of accuracy in data management and documentation. Time Management: Ability to prioritize multiple projects and meet deadlines in a dynamic environment. Public Speaking and Training: Experience speaking in large group settings and training teams on regulatory and quality requirements. Software Skills: Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) is required. Travel Requirements: Must be willing to travel to US and international based offices
US$90000 - US$120000 per annum
Cincinnati
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Director Regulatory Affairs
Director of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development. Key Responsibilities: Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence. Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts. Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities. Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents. Support due diligence activities for potential product acquisitions or partnerships. Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings. Monitor the regulatory landscape and communicate updates to stakeholders. Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues. Qualifications: Bachelor's degree in life sciences or related field; advanced degree preferred. Minimum 10 years of experience in pharmaceutical regulatory drug development. Proven track record in new chemical entity and line extension filings. Experience interacting with global health authorities and conducting due diligence. Strong knowledge of global pharmaceutical regulations and excellent communication skills.
Up to US$225000 per annum
Philadelphia
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Director, Global Regulatory Affairs
**Director, Global Regulatory Affairs - West Coast** A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets. As the guiding force behind our company's regulatory approach, your influence will be key to shaping market access and maintaining rigorous adherence to worldwide regulations. You'll join a dynamic team committed not only to innovation, but also exemplary standards that keep us at the forefront of our industry. **Role Responsibilities:** - Develop and implement cutting-edge Global regulatory strategies for clinical studies, marketing approvals, development plans and risk assessment, acting as the lead for the global regulatory program. - Prepare comprehensive submissions for Health Authority review. - Lead successful meetings with various global Health Authorities. - Manage regional teams towards cohesive global compliance efforts. - Provide High level oversight, direction, and mentorship to the team for general regulatory strategies and projects. - Reporting to CEO, CSO - Lead the submissions process **Skills Required:** *Regulatory Expertise*: 15+ years in the pharmaceutical industry, with deep understanding of pharmaceutical regulations necessary for steering products through complex approval processes globally. This candidate must have experience with gaining approval for new drug applications and biologic applications, as well as marketing authorizations, utilizing in house teams for the development of these products/submissions. *Strategic Guidance*: Ability provide long-term vision aligning with business objectives, and experience in managing early to late stage products, as well as post approval phases. This role will be leading the development of the company's global regulatory strategy *Leadership Abilities*: Superior managerial skill set fostering collaborative environment goal-oriented outcomes *Health Authority Interaction*: Must have experience leading FDA and/or EMA interactions/meetings This is an exciting opportunity to join a growing team that will make a difference in under-served patient's lives. If you have interest, please apply below.
Negotiable
San Francisco
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Regulatory Affairs Manager
Title: Regulatory Affairs Manager Summary: A leading global medical device company is seeking a Manager of Regulatory Affairs to join their innovative team. This key role involves managing regulatory submissions, including 510(k) filings, and working with both the US FDA and EU EMA to ensure compliance with regulatory standards. The Manager will collaborate with cross-functional teams to develop and execute regulatory strategies, prepare high-quality documentation, and support product development efforts. This position offers an exciting opportunity to contribute to the advancement of cutting-edge medical technologies that improve patient outcomes worldwide. The Manager will be responsible forโฆ Offering guidance, leadership, and coaching to Regulatory Affairs (RA) Associates. Providing expert technical advice on regulatory requirements for new products and modifications to existing ones. Managing, preparing, and reviewing regulatory submissions, including 510(k) filings and compliance with EU MDR standards. Collaborating with departments and cross-functional teams to communicate regulatory strategies effectively. Evaluating advertising and promotional materials to ensure alignment with local and international regulations. The Manager should have the following qualifications: Holds a bachelor's degree in engineering or physical/biological sciences. Possesses 8 years of experience in Regulatory Affairs, including 1+ year of direct or indirect management experience. Extensive experience with 510(k) filings and EU MDR submissions. Comprehensive knowledge of U.S. and international regulatory requirements for medical devices. Proven ability to provide leadership and mentorship to less experienced team members. Skilled in identifying, understanding, and resolving regulatory challenges.
Negotiable
England
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