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

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Regulatory Jobs

EMC Test Engineer

Exciting Opportunity: EMC Test Technician / Engineer About the Role Are you passionate about cutting-edge technology and innovation? Join our team of EMC specialists, where you'll play a vital role in testing the latest devices across a variety of industries. As an EMC Test Technician or Engineer, you'll take ownership of test projects, ensuring accurate and timely results for our clients. Whether you're starting your career or bringing valuable experience, we offer a flexible approach, providing training and development tailored to your expertise. We are committed to supporting your professional growth by offering all necessary training to help you thrive in this role. This is an incredible opportunity to be part of a globally respected organisation, enhance your technical skills, and build an exciting career in engineering. Key Responsibilities: Collaborate with customers, Engineers, and Project Managers to conduct EMC testing in screened enclosures and real-world environments. Provide expert support to clients before and during testing, particularly during any failure phase of the EMC test program. Maintain accurate records, including data logs and electronic documentation. Develop test procedures, including measurement uncertainty calculations and photographic documentation. Create test plans (as needed) and produce detailed test reports. Contribute to the advancement of test methods, equipment, and processes. Validate client requirements, which may involve site visits. Support the sales team by providing technical insights for quotations. Develop expertise in a specific area of EMC testing, such as rail, marine, or radio frequency compliance. Deliver training sessions to fellow engineers in specialist areas. What We're Looking For: Technician Level: A self-motivated, enthusiastic individual eager to develop technical skills. Willingness to work overtime and shift schedules when required. Engineer Level: All of the above, plus: Proven experience as an EMC Test Engineer in a professional test house environment. Strong knowledge of EMC regulations and testing standards. Hands-on experience with test equipment such as spectrum/network analysers, oscilloscopes, signal generators, or RF power meters. Desirable Skills (For Both Roles): Proficiency with IT systems, particularly Microsoft Word, Excel, and Outlook. Background in an electronics-based engineering role. Strong written and verbal communication skills with a customer-focused mindset. Why Join Us? Work with cutting-edge technology in a dynamic and fast-paced environment. Receive comprehensive training and career development opportunities. Be part of a globally recognised organisation known for excellence in testing and certification. Collaborate with industry experts and innovative clients. If you're ready to elevate your engineering career and work at the forefront of EMC testing, apply today!

Negotiable
Hampshire
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Senior Medical Writer

EPM is partnered with an innovative global biopharmaceutical company that is looking for a Senior Medical Writer to join their US team in the NJ/NY area. Key responsibilities: Creating clinical and regulatory documents including protocols, CSRs, CSPs, IBs, ICFs, CTDs, RMPs, PIPs, INDs, NSAs, BLAs, MAAs and additional briefing documents for various regulatory authorities like FDA, EMA, ICH, GCP, etc Developing clinical trial protocols and development plans Working cross-functionally with various teams like clinical, regulatory, and medical affairs Participating in internal and external meetings surrounding strategy, industry trends, evolving guidelines, and timelines A strong candidate for this role will bring: A PhD, PharmD, MD, or MSc A minimum of 3 years of direct medical writing experience in the biotech and/or pharmaceutical industry Prior experience with the above deliverables, documents, and submissions Experience working across various phases I-IV is a huge plus Experience in neurology is a plus This position is looking for someone to come into the office and is open to candidates in the USA. Apply now or reach out with questions!

US$140000 - US$150000 per annum
Jersey City
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Senior Medical Writer

EPM is partnered with an innovative global biopharmaceutical company that is looking for a Senior Medical Writer to join their US team in the NJ/NY area. Key responsibilities: Creating clinical and regulatory documents including protocols, CSRs, CSPs, IBs, ICFs, CTDs, RMPs, PIPs, INDs, NSAs, BLAs, MAAs and additional briefing documents for various regulatory authorities like FDA, EMA, ICH, GCP, etc Developing clinical trial protocols and development plans Working cross-functionally with various teams like clinical, regulatory, and medical affairs Participating in internal and external meetings surrounding strategy, industry trends, evolving guidelines, and timelines A strong candidate for this role will bring: A PhD, PharmD, MD, or MSc A minimum of 3 years of direct medical writing experience in the biotech and/or pharmaceutical industry Prior experience with the above deliverables, documents, and submissions Experience working across various phases I-IV is a huge plus Experience in neurology is a plus This position is looking for someone to come into the office and is open to candidates in the USA. Apply now or reach out with questions!

US$115000 - US$135000 per annum
New Jersey
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Senior Director Global Regulatory Affairs

Title: Senior Director Global Regulatory Lead A leading pharmaceutical company is growing their team with a Senior Director Global Regulatory Lead to develop and lead global regulatory strategies for complex projects. This is an exciting chance to join a leading company in the industry to support high-level strategies across the entire drug development lifecycle. Responsibilities: The Senior Director will be responsible for complex or highly complex or multiple projects. Lead the Global Regulatory Teams and applicable sub-working groups, such as the Label Working Group, and represents Global Reg teams at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Senior Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Qualifications 10+ years of Regulatory Affairs experience in the pharmaceutical industry Bachelor's Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline strongly preferred Strong working knowledge of drug development process and regulatory requirements US and Global perspective preferred

US$240000 - US$280000 per annum
Boston
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Senior Manager Regulatory Affairs

Title: 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 new team member will be responsible for the management and leadership of the Regulatory Affairs department, allocating and managing department resources to accomplish both departmental and corporate objectives. 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. MUST HAVE 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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Quality Assurance Specialist

We are working with a leading pharmaceutical company based in Copenhagen that are dedicated to the development, manufacturing, and commercialisation of small molecule therapeutics. Their mission is to improve patient outcomes through innovative and high-quality products. We are seeking a detail-oriented Quality Assurance Specialist to join the client on a 12 month contract, playing a critical role in ensuring that the client's small molecule products meet all regulatory and quality standards. This position involves working closely with various departments to maintain compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. Key Responsibilities: Review and approve documentation related to the manufacturing, testing, and release of small molecule products, including batch records, SOPs, and validation protocols. Ensure compliance with GMP, EMA, and other regulatory requirements, conducting internal audits and participate in external audits. Collaborate with the Quality Control team to ensure that all testing procedures are followed and that results meet quality standards. Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs) to address issues and prevent recurrence. Provide training to staff on quality-related topics and ensure that everyone is aware of and adheres to quality standards. Participate in continuous improvement initiatives to enhance quality processes and systems, identifying areas for improvement and implementing changes as needed. Conduct risk assessments and develop mitigation strategies to ensure product quality and patient safety. Qualifications: Bachelor's degree in Chemistry, Biology, Pharmacy, or a related field. Minimum of 5 years of experience in Quality Assurance within the pharmaceutical industry, with a focus on small molecule products. Strong understanding of GMP, EMA, and other regulatory requirements. Strong familiarity with quality management systems. Contract: Start date: ASAP 12 month contract 40 hours per week Copenhagen

Negotiable
Copenhagen
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Director of EHS

We are currently working with a leading pharmaceutical company looking for an EHS Director to join their team. This is an exciting opportunity to build a long-term career in a dynamic and innovative environment. You will be responsible for: Overseeing all environmental, safety, and industrial hygiene programs and policies. Leading a team, improving EHS standards and ensuring compliance with all relevant regulations. Developing EHS strategies aligned with the wider business goals and strategy. Promoting a strong safety culture with shared responsibility and best practices and collaborating with relevant stakeholders to foster EHS awareness. Building a creative EHS team, creating opportunities for growth for the whole team. As an ideal candidate you should have the following qualifications: Bachelor's degree in environmental science, Occupational Health and Safety, Engineering, or related fields. 15+ years' experience in EHS roles, ideally within pharmaceuticals or other heavily regulated industries. Experience in change management. Thorough understanding of EHS regulations and policies. Excellent communication and leadership skills. Fluent French and English. If this opportunity interests you, please apply! NOTE: Only shortlisted candidates will be contacted.

Negotiable
Neuchรขtel
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Freelance Regulatory/Clinical Affairs Specialist - MedDev

EPM is urgently looking for a freelance Regulatory/Clinical Affairs Specialist to support one of our key medical device clients on a 12-month assignment as soon as possible. Below is a brief overview of the role and its requirements: Regulatory Affairs / Clinical Affairs Specialist Medical Device Client 12-month contract (Likely extension to 24 months) Ramp-up project (Start with 20 hours, increasing to full-time by Summer) April Start Remote role Must have experience with the following: USA market experience (510k, De Novo, PMA) Strong interactions with the FDA / Pre-Submissions Other regional experience (Canada, UK, EU, etc.) Medical Device Experience - across various classes (Advantageous if experience in Pharma) Early-stage devices, from viability to market Ability to evaluate resources, regulatory pathways, and clinical pathways This client is one of EPM's largest customers with extensions innovation and products coming to the market. If this role is of interest to you, please apply.

Negotiable
Republic of Ireland
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Project Manager - Medical AI Software

My client is building the first universal AI Operating System to lay the foundation for Biological Artificial Superintelligence (BASI). This OS integrates a suite of AI agents that decode complex biology, accelerate research, and dramatically increase productivity. Acting as copilots,My clients agents will automate drug discovery and diagnostics and power next-gen pharma companies. My client will be powered by the world's largest federated multimodal patient data network, a robotized lab, leading AGI technologies, and cutting-edge multimodal foundation models and LLMs. Context: Launching an innovative AI solution that analyses Whole Slide Images (WSI) to predict patient-specific mutations. We are seeking an experienced Deployment Manager to lead the implementation of our groundbreaking AI medical device across multiple laboratory sites. This role offers a unique opportunity to bridge the gap between cutting-edge AI technology and clinical practice. Start Date: Ideally early April, but mid-April would work too Duration: 3.5 months Part time: Ideally, 1/2 day a day (morning or afternoon), but if that's not possible, it could be 2.5 days a week (or once for 2 days, once for 3 days) Languages: English and French speaker Location: Based in France (Paris) Tasks: Strategic Project Management: Drive deployment planning and execution across laboratory sites Coordinate with technical teams to ensure smooth implementation Establish and maintain project timelines and milestones Client Success & Training: Deliver comprehensive training programs for end-users Serve as the primary point of contact for client communication Manage stakeholder expectations and relationships Collaborate with Product team to drive continuous improvement Regulatory Compliance: Oversee the creation and maintenance of regulatory documentation Ensure deployments meet all necessary compliance requirements Collaborate with Quality Assurance team to maintain standards Required Skills/Competences: Proven track record of successful client-facing project delivery Excellence in stakeholder communication and relationship management Strong organisational and documentation skills Ability to start immediately or with short notice Optional Skills/Competences: Experience with medical device deployment Experience in a regulated environment

Negotiable
Paris
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Senior Regulatory Affairs - Documentation Specialist

Job Title: Senior Regulatory Affairs Specialist Location: France (Hybrid) Start Date: Within the next month Job Type: Full-time (Consultant, Freelancer, or Contractor) Industry: Medical Devices Key Responsibilities: Documentation Specialist: Lead and manage all regulatory documentation processes, ensuring compliance with local and international regulations. Regulatory Submissions: Prepare and submit regulatory filings to relevant authorities, including CE marking, FDA submissions, and other global regulatory requirements. Quality Team Collaboration: Work closely with the quality team to ensure all regulatory requirements are met and maintained throughout the product lifecycle. Project Support: Provide regulatory support for ongoing projects, ensuring timely and compliant product development and market entry. Compliance Monitoring: Stay updated with regulatory changes and ensure the company's products and processes comply with current regulations. Risk Management: Identify and mitigate regulatory risks associated with product development and market entry. Training and Mentorship: Provide training and mentorship to junior regulatory affairs staff and other team members. Qualifications: Experience: Proven experience as a consultant, freelancer, or contractor in regulatory affairs within the medical device industry or own company set up. Knowledge: In-depth knowledge of regulatory requirements and standards for medical devices, including ISO 13485, MDR, and FDA regulations. Skills: Excellent documentation and communication skills, strong attention to detail, and the ability to work collaboratively in a hybrid work environment. Languages: Proficiency in English and French is preferred.

Negotiable
Paris
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Regulatory Affairs Specialist

We have a current opportunity for a Regulatory Affairs Specialist on a contract basis. The Regulatory Affairs Consultant will be responsible for providing strategic guidance on regulatory requirements and submissions for medical devices. This role involves ensuring compliance with global regulations, preparing and managing regulatory submissions, and acting as a liaison with regulatory agencies. Key Responsibilities: Develop and implement regulatory strategies for medical device products throughout their lifecycle. Prepare, review, and submit regulatory submissions, including 510(k), PMA, CE Mark, and other international submissions. Ensure compliance with applicable regulations, standards, and guidelines, including FDA, EMA, and other global health authorities. Monitor and interpret regulatory requirements and changes, providing proactive advice to internal teams. Act as the primary point of contact with regulatory agencies, managing communications and negotiations to facilitate product approvals. Conduct risk assessments and provide recommendations to mitigate regulatory risks. Collaborate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure regulatory compliance. Provide training and support to company staff on regulatory compliance matters. Maintain regulatory documentation and records in accordance with company policies and procedures. Qualifications: Bachelor's degree in life sciences, health sciences, pharmacy, or a related field; advanced degree preferred. 3-5 years of experience in regulatory affairs within the medical device industry. Strong knowledge of regulatory requirements and submission processes for medical devices. Experience with regulatory submissions and interactions with health authorities. Regulatory Affairs Certification (RAC) or equivalent certification preferred. Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work independently and manage multiple projects simultaneously. Proficiency in regulatory software and tools.

Negotiable
Massachusetts
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Director, Regulatory Strategy (Hybrid)

Director, Regulatory Strategy - Global Biopharmaceuticals (Hybrid) A leading global biopharmaceutical company is seeking a Director of Regulatory Strategy to drive regulatory success for complex and high-impact programs. This role is responsible for defining and executing global regulatory strategies, collaborating cross-functionally, and ensuring compliance with evolving international regulatory requirements. Key Responsibilities: Develop and lead global regulatory strategies to support product development and approvals. Provide strategic regulatory guidance to cross-functional teams, ensuring alignment with business objectives. Oversee regulatory submissions and interactions with global health authorities, including the FDA. Serve as the regulatory lead for cross-functional project teams and external partnerships. Anticipate regulatory risks, develop mitigation strategies, and adapt approaches to evolving regulations. Collaborate with market access and medical affairs teams to support product value strategies. Monitor industry trends and lead regulatory due diligence for potential business opportunities. Mentor and develop junior regulatory professionals within the team. Qualifications & Experience: Bachelor's degree in a scientific discipline required; an advanced degree (PharmD, PhD, MD) is a plus. 8+ years of experience in the pharmaceutical or biotechnology industry, with at least 6 years in regulatory affairs. Strong knowledge of global regulatory requirements and the drug development lifecycle. Experience with regulatory submissions and interactions with health authorities. Proven leadership in cross-functional teams with excellent communication and problem-solving skills. Ability to thrive in a hybrid work environment and manage multiple priorities. This is an exciting opportunity to lead regulatory strategy within a dynamic and fast-paced environment. If you are a seasoned regulatory professional looking to make a strategic impact, we encourage you to apply.

Negotiable
Boston
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