CMC Specialist
* Authoring high-quality CMC documentation for US/ EU / UK countries, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle. * Preparing CMC response to health authority questions during development, registration and product lifecycle. * Actively participating as a member of the global Regulatory CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. * Identifying the required documentation for global submission and negotiate the delivery of approved technical source documents in accordance with project timelines. * Identifying content, quality and/or timeliness issues with source management, or any other potential authoring issues that may impact submission quality or timelines, as early as possible. * Handling of Change control & its assessment in tools like Veeva, Trackwise, etc * Keeping knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends. * Assume activities in working with client tools and coordination/collection/archive of source documentation needed for direct submission to HAs, other database entry activities (Specialized department functions). * For deliverables in scope, supporting responses to inquiries from clients in response to inspection activities and may provide support during regulatory agency questions * Coordinating with team when there is a regional, global or therapeutic area impact across multiple countries * Ability to run training and awareness sessions on CMC writing processes and ability to clearly articulate expectations of the CMC writing process to stakeholders * Meeting defined targets on productivity, quality and compliance, as set by and overseen by management * Meeting strategic targets for CMC deliverables as defined for the function, and communicates progress against these targets or issues which affect these targets, and proposes remediation * Managing the day-to-day activities of direct reports, including project assignments and scheduling. Mentor and train junior staff and other members of the team
Negotiable
United States of America
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Senior Manager Regulatory Affairs
A leading global Medical Device company is seeking a Senior Manager of Regulatory Affairs to join their team on-site in their downtown Atlanta office. This is an exciting opportunity to support high risk innovative products and join a high performing team to achieve global approvals. What You'll Work On Recruit, coach, and develop organizational talent. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Create an entrepreneurial environment. Provide direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. Manage and coach a team of regulatory employees. Keep the organization's vision and values at the forefront of decision-making and action. Demonstrate effective change leadership. Build strategic partnerships to further departmental and organizational objectives. Develop and execute organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Monitor compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.). Make decisions regarding work processes or operational plans and schedules to achieve departmental objectives. Develop, monitor, and appropriately adjust the annual budget for department(s). Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives. Assess proposed regulations and communicate new requirements to the organization. Required Qualifications Bachelor's degree in a related field or an equivalent combination of education and experience. Minimum 9 years of related work experience. Hands-on experience authoring PMA submissions Experience working with Class III implantable devices. Provide direction and monitor progress of exempt specialists and/or supervisory staff toward departmental goals. Monitor costs of projects and of human and material resources within a department or unit. Monitor company-wide indicators such as market share and profitability. Monitor external environment in area of technical or professional responsibility. Develop and/or identify new work processes and the improved utilization of human and material resources within the assigned or related functions or groups. Preferred Qualifications Master's degree. Knowledge of submission and registration types and requirements. Effective verbal and written communication with diverse audiences and teams. Analytical thinking with good problem-solving skills. Experience managing and leading a team. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). Ability to lead and manage multiple and competing priorities and manage programs. Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies. Experience with medical device software requirements and software regulations.
US$150000 - US$200000 per annum
Atlanta
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Head of Quality and Regulatory
Title: Head of Regulatory and Quality Summary: Join a pioneering leader in medical technology dedicated to advancing patient care and safety. Our client is at the forefront of developing innovative solutions that address critical gaps in diagnostic accuracy and infection prevention. As the Head of Regulatory and Quality, you will play a pivotal role in shaping the regulatory strategy, ensuring compliance and driving quality initiatives that align with our mission to deliver life-changing medical innovations. If you're a result driven professional with a passion for fostering excellence and ensuring the highest standards, we invite you to lead and inspire our dynamic team in transforming healthcare. The RA/QA Head will be responsible forโฆ Guide and mentor the Quality and Regulatory team, setting goals, providing feedback, and fostering professional growth to drive organizational excellence. Manage regulatory submissions (510k and EU MDR), provide expertise on domestic and international requirements, and ensure compliance in labeling, marketing, and product documentation. Oversee the development and enhancement of the Quality Management System, ensuring audit-readiness, adherence to design controls, and proactive resolution of quality issues. Lead post-market activities, including complaint handling, root cause analysis, trend monitoring, vigilance reporting, and responses to regulatory agencies like FDA and ISO. Direct supplier quality controls, collaborate with cross-functional teams on new product development, and ensure regulatory and quality standards in materials, processes, and product launches. The RA/QA Head should have the following qualifications: Bachelor's degree in life sciences, engineering, or a related field required; graduate degree strongly preferred. Over 10 years in medical technology or life sciences, including 5+ years in quality or regulatory roles, with a preference for startup experience. In-depth knowledge of U.S. and international regulations (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971, ISO 10993), including experience with FDA audits and quality system implementation. Proven ability to manage all phases of product development, from concept through commercialization, ensuring regulatory compliance and operational excellence. Effective in fast-paced, dynamic environments with changing priorities, and open to travel up to 30% of the time.
Negotiable
Seattle
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Senior Regulatory Affairs Manager
Title: Regulatory Affairs Senior Manager Summary: A leading, global pharmaceutical client of ours is looking to hire a Senior Manager of Regulatory Affairs at their prescription drug specific subsidiary, based out of New Jersey. This rapidly growing client has drugs spanning many different therapeutic areas from anti-invective's to psychiatry. The main function of the Manager is to provide support on writing and submitting NDAs, preparing FDA meeting requests, and working with cross-functional teams to compile and submit high quality regulatory submissions. This role will give you a great opportunity to contribute to the companies mission of producing high-quality and accessible medicines that those in need. The Manager will be responsible forโฆ Preparing and submitting new NDAs, 505(b)(2)s, INDs, ANDAs, and meeting requests to the FDA Thoroughly reviewing submission documentation to ensure internal consistency, adherence to relevant FDA guidelines, and to uphold regulatory excellence Collaborating on the establishment of project time lines, including pre-NDA and pre-ANDA activities, and ensuring milestone deadlines are achieved Actively participating in project team meetings, providing regulatory expertise to support complex and/or combination products Overseeing change management activities for existing commercial products, ensuring they are executed correctly and on schedule The Manager should have the following qualifications: Bachelor's or Master's degree 5-8 years specifically within regulatory affairs, 7+ years within the pharmaceutical industry Extensive experience with regulatory activities in the US, specifically with NDA and 505(b)(2) submissions Strong critical and logical thinking skills with the ability to analyze problems Excellent verbal and written presentation and communication skills
Negotiable
New Jersey
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Director of Regulatory Strategy
Director of Regulatory Strategy This position is with a rapidly growing pharmaceutical company that is committed to advancing transformative therapies. In this role, you will have the rare opportunity to lead regulatory strategy for innovative pharmaceutical products, and make a meaningful impact on patient health. You will work cross functionally 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 labelling 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.
Negotiable
Conshohocken
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Global Regulatory Lead
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$175000 - US$195000 per annum
Massachusetts
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Regulatory Affairs Specialist
Job Title: Regulatory Affairs Specialist Location: Tokyo, Japan Job Type: Full-time (permanent) Our client, a leading pharmaceutical company dedicated to improving global health through innovative medicines. They are committed to excellence in research, development, and regulatory compliance. Job Summary: The Regulatory Affairs Specialist will be responsible for ensuring that the products comply with all regulations and standards set by the Japanese regulatory authorities. This role involves preparing and submitting regulatory documents, maintaining product licenses, and collaborating with cross-functional teams to achieve regulatory compliance. Key Responsibilities: Prepare and submit regulatory documents for product registration, amendments, and renewals to the Pharmaceuticals and Medical Devices Agency (PMDA). Maintain and secure product licenses, ensuring compliance with local regulations, company policies, and global standards. Monitor and interpret regulatory requirements and guidelines, providing strategic advice to internal teams. Collaborate with R&D, Quality Assurance, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle. Manage regulatory submissions, including Clinical Trial Applications (CTAs), New Drug Applications (NDAs), and post-marketing surveillance reports. Liaise with regulatory authorities and represent the company in regulatory meetings and inspections. Ensure timely reporting of adverse events and product complaints in accordance with regulatory requirements. Maintain up-to-date knowledge of regulatory changes and industry trends. Qualifications: Bachelor's degree in Pharmacy, Life Sciences, or a related field. Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry. In-depth knowledge of Japanese pharmaceutical regulations and guidelines. Strong project management and organizational skills. Excellent communication and interpersonal skills. Proficiency in both Japanese and English (written and spoken). Ability to work independently and as part of a team. Attention to detail and a proactive approach to problem-solving.
Negotiable
Tokyo
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Senior Medical Writer/AD, Medical Writing - Regulatory
Job Title: Senior Medical Writer OR Associate Director, Medical Writing (Regulatory) Location: Hybrid schedule in San Francisco, New Jersey, or New York Position Overview: A bio-pharmaceutical company is seeking a highly skilled and experienced Senior Medical Writer or Associate Director, Medical Writing to join their team. In this role, you will lead and manage the medical writing activities across clinical, non-clinical and regulatory verticals. You will work closely with cross-functional teams to support regulatory submissions, clinical study reports, protocols, IBs, NDAs, and other key documents. Key Responsibilities: Lead the development, review, and finalization of clinical, non-clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions. Collaborate with clinical and regulatory teams to ensure accurate and timely completion of documents. Provide strategic input and guidance on medical writing processes and best practices. Ensure compliance with regulatory requirements and company standards. Qualifications: Minimum of 3 years of medical writing experience in the bio-pharmaceutical industry for the Senior Medical Writer level. Minimum of 6 years of medical writing experience to be considered for the Associate Director position. Proven track record of leading and managing medical writing projects. Strong understanding of regulatory requirements and guidelines (e.g., ICH, FDA, EMA). Excellent written and verbal communication skills. Ability to work effectively in a hybrid work environment and manage multiple priorities. What We Offer: Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and inclusive work culture. Flexible hybrid work schedule. Only available for US-based candidates. Don't hesitate to apply to learn more!
US$140000 - US$190000 per annum
United States of America
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Head of QA/RA
We have a current opportunity for a Head of QA/RA on a permanent basis. The position will be based in Oberhonnefeld-Gierend. For further information about this position please apply. Job Summary: The Head of Quality and Regulatory Affairs will oversee and manage all quality and regulatory functions for Class I and Class II medical devices. This role ensures compliance with relevant regulations, standards, and guidelines, while driving continuous improvement in quality management systems. Key Responsibilities: Quality Management: Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and other relevant standards. Ensure compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). Lead internal and external audits, including those by regulatory bodies and notified bodies. Oversee the management of non-conformities, CAPAs (Corrective and Preventive Actions), and continuous improvement initiatives. Ensure product quality and safety through rigorous testing, validation, and documentation processes. Regulatory Affairs: Develop and execute regulatory strategies to ensure timely product approvals and market access. Prepare and submit regulatory submissions, including 510(k) notifications, to relevant authorities (e.g., FDA, EU MDR). Monitor and interpret regulatory changes and ensure the company remains compliant with all applicable regulations. Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing. Manage post-market surveillance activities, including adverse event reporting and product recalls. Leadership and Management: Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of excellence and continuous improvement. Set departmental goals and objectives, and monitor performance against these targets. Collaborate with other departments to ensure alignment and integration of quality and regulatory activities. Represent the company in regulatory inspections and audits, and communicate effectively with regulatory authorities. Documentation and Reporting: Ensure accurate and timely documentation of all quality and regulatory activities. Prepare and present reports on quality and regulatory performance to senior management. Maintain up-to-date records of regulatory submissions, approvals, and correspondence. Qualifications: Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences, Quality Management). Minimum of 15+ years of experience in quality and regulatory roles within the medical device industry, with a focus on Class I and Class II products. In-depth knowledge of ISO 13485, FDA regulations, EU MDR, and other relevant standards and guidelines. Proven track record of successful regulatory submissions and product approvals. Strong leadership and team management skills. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced, dynamic environment. Preferred Qualifications: Certification in quality management (e.g., ASQ Certified Quality Manager). Experience with international regulatory submissions and approvals.
Negotiable
Oberhonnefeld-Gierend
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