Regulatory

Regulatory

At any time, there are more than300,000 clinical studieshappening around the world. The process for bringing new pharmaceuticals to the market is prolonged due to regulation placed on the drugs sector in order to protect public safety.The Federal Institute for Drugs and Medical Devices(Bundesinstitut fรผr Arzneimittel und Medizinprodukte or BfArM) is the legal narcotics and medical device regulatory authority in Germany. According to the BfArM, โ€œThey are involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors.โ€

The effects of Brexit are being felt across many different industries in Germany, particularly in the pharma regulatory sector. The BfArM is one of the major licensing authorities in the EU and actively supports theEuropean Medicines Agencyin all key areas of drug authorisation and drug safety, together with thePaul Ehrlich institute, more than480 experts bring their expertise to around 130 scientific bodiesof the EMA.

According toProf. Dr Karl Broich, President of the BfArM, โ€œThe organisation makes significant contributions to the supply of patients in Europe with safe medications and will increase these contributions in the years to come after Brexit and the loss of the British licensing authority, the number of authorisation processes will also increase, for Germany in particular.โ€

Increased demand for regulation following Brexit will likely see substantial growth in the market over the next number of years. At the moment theBfArM employs roughly 1,100 employeesacross many different specialisms including physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants, administrative staff. More than 130 of their nearly 1,100 employees will reach the age of 65 within the next 5 years, in other words, 12 % of the staff will retire in the near future. This will free up numerous jobs that will need to be filled as Europe becomes more reliant on Germany to spearhead regulation following the UKโ€™s exit of the EU.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place talent in the regulatory industry in Germany and across Europe.

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Benefits of working with us

Experience

We have over a decadeโ€™s worth of experience as a leading talent partner in Life Sciences & Pharma.

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A vast, global network of the best, in-demand professionals, working with the worldโ€™s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

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Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

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Regulatory Jobs

Regulatory Affairs Manager

ABOUT: Are you passionate about advancing treatments for life-changing conditions? This global specialty pharmaceutical leader is transforming the landscape of genetic, metabolic, and systemic disorders. With a cutting-edge focus on melanocortin technology, they are on a mission to build a world-class melanocortin house-bringing hope to patients with life-threatening and acute conditions. With 10 products in the pipeline, ranging from pre-clinical to commercial, the company is looking to bring on a Regulatory Manager to their US site (California; However, this role can be remote)*. Key Responsibilities: Assist in the development of the ongoing global regulatory strategy Submissions of NDAs and amendments Applications and submissions to the FDA as required following post approval obligations and commitments, as well as prepare response to questions raised by FDA Maintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure) Support Quality and Pharmacovigilance colleagues in systems management Prepare and/or collate all documentation to support clinical trial applications Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging Manage packaging material manufacturing and create secondary packaging material Review and approve contract manufacturer's specifications and packaging documents Qualifications: Minimum 5 years pharmaceutical industry experience Proven experience in preparation of New Drug Applications Proven experience in regulatory management of centrally approved products Understanding of Orphan Drug requirements Proven understanding of eCTD Modules 1-5 Preparation of marketing authorization applications in eCTD format Proven experience in labelling, pricing and reimbursement procedures (desirable) Preparation of CTAs to support clinical trials (desirable)

Negotiable
San Francisco
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Regulatory Affairs Project Manager

The Company: My client is a purpose-driven organisation focused on pioneering and commercialising novel health care solutions for individuals with unmet medical needs. With over 30 years of research in their clinical pipeline, they provide patients with new treatment options and extend their expertise into broader health care applications. As a rapidly growing company, they seek candidates who share their entrepreneurial spirit and are excited to contribute to a dynamic, international team working toward impactful results. The Role: The Regulatory Affairs Project Manager will be responsible for staying current with regulatory changes in key markets, preparing documentation for New Drug Applications, and managing post-marketing requirements, including market access and IRB submissions. They will also oversee regulatory submissions for clinical programs, orphan drug designation, and labelling/packaging material supply. As part of our client's fast-growing, dynamic international team, this candidate will help deliver impactful health care innovations while working closely with leadership to meet deadlines. Key Responsibilities: Regulatory Assist in the development of the ongoing global regulatory strategy Submissions of NDAs and amendments Applications and submissions to the FDA as required following post approval obligations and commitments, as well as Prepare response to questions raised by FDA Maintain all approvals by submitting annual updates as needed (example Orphan designations, Investigator Brochure) Support Quality and Pharmacovigilance colleagues in systems management Clinical Trial Applications Prepare and/or collate all documentation to support clinical trial applications File substantial amendments as required Assist sites in submitting applications to IRBs, and preparing responses to questions raised by IRBs and updated documentation as required Maintain the Investigator Brochure and Investigational Medicinal Product Dossier Ensure investigation medicinal product is supplied to the study sites in compliance with all regulatory requirements, including packaging Labelling & Packaging Obtain approvals on labelling text and design by competent authorities Manage packaging material manufacturing and create secondary packaging material Review and approve contract manufacturer's specifications and packaging documents Qualifications: Post-graduate qualifications in Pharmacy, Biological Sciences, or related discipline Minimum 5 years pharmaceutical industry experience Proven experience in preparation of New Drug Applications Proven experience in regulatory management of centrally approved products Understanding of Orphan Drug requirements Proven understanding of eCTD Modules 1-5 Proven experience in labelling, pricing and reimbursement procedures (desirable) Preparation of marketing authorisation applications in eCTD format (desirable) Preparation of CTAs to support clinical trials (desirable)

Negotiable
San Francisco
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RAQA Manager

Job Title: RAQA Manager (Regulatory Affairs, Quality Assurance) Location: Kuala Lumpur, Malaysia Working Arrangement: On-site Job Summary: We are seeking an experienced RAQA Manager in Kuala Lumpur. The ideal candidate will have a strong background in regulatory affairs and quality assurance within the pharmaceutical or consumer health sectors. This role involves working closely with distributors, conducting audits, and ensuring compliance with regional regulations. Key Responsibilities: Oversee regulatory affairs and quality assurance activities to ensure compliance with local and international standards. Manage relationships with distributors, including conducting regular audits and compliance checks. Develop and implement quality assurance policies and procedures. Ensure all products meet regulatory requirements and quality standards. Provide guidance and support to internal teams on regulatory and quality matters. Stay updated on regulatory changes and ensure the company's practices are aligned with current regulations. Prepare and submit regulatory documents to relevant authorities. Coordinate with regional teams in Malaysia and SEA region to ensure consistent quality and regulatory practices. Key Criteria: 5+ years of experience in regulatory affairs and quality assurance in the pharmaceutical or consumer health industry. Proven experience in working with distributors and conducting audits. Regional experience in Malaysia and SEA region is preferred. Strong understanding of local and international regulatory requirements. Excellent communication and interpersonal skills. Ability to work independently and manage multiple projects simultaneously. Detail-oriented with strong analytical and problem-solving skills.

Negotiable
Kuala Lumpur
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RAQA Manager

Job Title: RAQA Manager Location: Kuala Lumpur, Malaysia Job Summary: We are seeking an experienced RAQA Manager to join our team in Kuala Lumpur. The ideal candidate will have a strong background in regulatory affairs and quality assurance within the pharmaceutical or consumer health sectors. This role involves working closely with distributors, conducting audits, and ensuring compliance with regional regulations. Key Responsibilities: Oversee regulatory affairs and quality assurance activities to ensure compliance with local and international standards. Manage relationships with distributors, including conducting regular audits and compliance checks. Develop and implement quality assurance policies and procedures. Ensure all products meet regulatory requirements and quality standards. Provide guidance and support to internal teams on regulatory and quality matters. Stay updated on regulatory changes and ensure the company's practices are aligned with current regulations. Prepare and submit regulatory documents to relevant authorities. Coordinate with regional teams in Malaysia and SEA to ensure consistent quality and regulatory practices. Key Criteria: 5+ years of experience in regulatory affairs and quality assurance in the pharmaceutical or consumer health industry. Proven experience in working with distributors and conducting audits. Regional experience in Malaysia and SEA region is preferred. Strong understanding of local and international regulatory requirements. Excellent communication and interpersonal skills. Ability to work independently and manage multiple projects simultaneously. Detail-oriented with strong analytical and problem-solving skills.

Negotiable
Kuala Lumpur
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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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Principal Regulatory Affairs Specialist

Title: Principal Regulatory Affairs Specialist A leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products. Responsibilities: Developing strategies for regulatory approval on a global scale for new and modified products Prepare regulatory applications for FDA and international agencies Coordinate, compile, and submit regulatory submissions such as EU dossiers, Premarket notifications, PMA supplements, change notifications, etc. Maintain annual licenses, registrations, and listing information Act as the subject matter expert (SME) for audits and inspections with internal and external authorities Review and edit Ad Promo material Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems. Ensures that details of any new or modified regulations are distributed to appropriate team members. Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release. Qualifications: Minimum 5+ years of experience with Class II and/or Class III medical devices Experience authoring and submitting 510k applications and PMA supplements RAC Certification Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Strong technical writing skills Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations Ability to travel 5%, including international travel

US$95500 - US$191000 per annum
Pleasanton
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Material Compliance Specialist

Material Compliance Specialist - 6 month contract We are seeking a dedicated Material Compliance Specialist for an esteemed client within the dynamic Medical Device sector. This contract position, based in picturesque Switzerland, is perfect for someone with a keen eye on ensuring materials meet stringent regulatory and quality standards. As our ideal candidate: You will be responsible for managing all aspects of material compliance using GSMS (Global Safety Management System) Utilize Green Bill knowledge to ensure environmental considerations are met during product development. Conduct thorough material testing that aligns with industry best practices while keeping patient safety at heart. Prepare detailed safety data sheets that accurately reflect properties and handling instructions of materials used. Engage actively in Verification & Validation (V&V) testing processes, contributing towards robust medical device production protocols. Skills: Green Bill Understanding: Apply principles aimed at reducing environmental impact throughout the manufacturing process Material Testing Acumen: Perform rigorous tests on raw materials as well as finished products guaranteeing they adhere to high-quality standards Safety Data Sheet Compilation: Create comprehensive documentation detailing hazardous information and protective measures related directly or indirectly linked substances/products Verification & Validation Expertise: Execute systematic V&V activities essential for confirming medical devices perform safely/effectively prior market entry Dive into this challenge where precision meets passion-apply today! **Please note, only those with the rights to work in Switzerland will be considered.

Negotiable
Switzerland
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Principal Regulatory Affairs Specialist

Title: Principal Regulatory Affairs Specialist A leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. This is an exciting opportunity to join an innovative company working on breakthrough products. Responsibilities: Developing strategies for regulatory approval on a global scale for new and modified products Prepare regulatory applications for FDA and international agencies Coordinate, compile, and submit regulatory submissions such as EU dossiers, Premarket notifications, PMA supplements, change notifications, etc. Maintain annual licenses, registrations, and listing information Act as the subject matter expert (SME) for audits and inspections with internal and external authorities Review and edit Ad Promo material Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems. Ensures that details of any new or modified regulations are distributed to appropriate team members. Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release. Qualifications: Minimum 5+ years of experience with Class II and/or Class III medical devices Experience authoring and submitting 510k applications and PMA supplements RAC Certification Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC). Strong technical writing skills Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations Ability to travel 5%, including international travel

US$95500 - US$191000 per annum
Pleasanton
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Payroll Specialist

The Opportunity A global manufacturing company is seeking a brand new, skilled Payroll Specialist to join our well-established Payroll Team. As a Payroll Specialist, you will be responsible for processing the payroll for 500+ employees in Germany. The Team The payroll Team is highly regarded and plays a critical role in the HR Operations department. Sitting on a global payroll team, you will be responsible for one of the main German sites as the Payroll Specialist. Key Responsibilities Ensure accurate and timely payment of salaried staff Provide high-quality customer service to internal and external customers Support cross-functional teams as needed, both within the department and broader business Maintain the integrity and security of all payroll data Maintain internal control procedures to safeguard the integrity of the company Assist with Year End processing Support project and transformation needs Qualifications We are looking for a candidate with experience in payroll, who is comfortable working in a fast-paced and changing environment. Key attributes include: 4+ years of payroll experience Experience of working in a team Comfort and experience of working in a fast-paced and changing working environment Experience and ability to think outside the box to solve problems Knowledge of payroll and pension legislation and compliance Adherence to payroll and statutory deadlines to mitigate risk of penalties and delayed payments Strong diligent, analytical skills to breakdown problems and queries as they arise Experience of system implementation projects (desirable) Experience of process mapping of payroll processes (desirable)

Negotiable
Frankfurt (Oder)
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Senior Director of Regulatory Affairs Advertising & Promotion

Title: Senior Director of Regulatory Affairs Ad/Promo Summary: A global biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Senior Director of Regulatory Affairs Ad/Promo to join their team! The team is growing rapidly as they have had great commercial success and multiple products in their pipeline. They are looking for someone who is very dedicated and has proven success in the Regulatory Ad/Promo field, specifically within branded prescription products. This role is based out of either their Pennsylvania or Boston location and would give you an amazing opportunity to contribute to the company's mission to improve patient's lives. The Senior Director will be responsible forโ€ฆ Reviewing promotional materials to assess compliance with regulations, guidance documents, and best practices Representing commercial regulatory team internally/cross-functionally as well as externally Serve as internal Regulatory Ad/Promo expert, acting as a credible, influential, and respected spokesperson Assume leadership role on commercial impact of new campaigns and product labelling as well as provide strategic guidance on corporate communications and appropriate pre-approval communications with managerial oversight The Senior Director should have the following qualifications: BS in life sciences or related field, advanced degrees are strongly preferred 12+ years of pharmaceutical/biopharmaceutical experience, 6+ years specifically within ad/promo of prescription drugs Capable of developing/implementing commercial strategies and managing complex negotiations Excellent verbal and written communication skills

Negotiable
Boston
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Director of Regulatory Labeling

Title: Director of Regulatory Labelling Summary: A global Biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Director of Regulatory Labelling to join their team! The team is growing rapidly as they have had great commercial success and multiple products in their pipeline. They are looking for someone who is very dedicated and has proven success in the Regulatory Labelling field in the US and EU. This role is based on their Pennsylvania location and would give you an amazing opportunity to contribute to the company's mission to improve patient's lives. The Director will be responsible for... Providing regulatory expertise to drug development teams, as well as controlling the consistency of labelling throughout process Provide Regulatory labelling expertise and guidance to cross functional teams to align with US and EU requirements Managing FDA-required SPL documents Coordinating EU SmPC updates and managing translations, linguistic reviews, and readability for EU products Coordinate US labelling submissions, approval, and implementation activities internally and externally The Director should have the following qualifications: BS in life sciences or related field, advanced degrees are strongly preferred 10+ years of branded Regulatory Labelling experience for pharmaceutical products Strong global understanding of labelling requirements Strong communication and teamwork skills

Negotiable
Pennsylvania
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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
Apply
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