Regulatory Affairs Specialist

PQE Group; Leverkusen; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

PQE Group is seeking a Regulatory Affairs Specialist in Leverkusen to support a major transfer project within the pharmaceutical industry. This role requires strong knowledge of EU regulations, 6+ years of experience, and fluency in German. The successful candidate will oversee document submissions and collaborate with various stakeholders to ensure compliance during a significant operational transition.

Qualifikationen

• 6+ years hands-on experience in Regulatory Affairs within the EU pharmaceutical or biotech industry.
• Strong knowledge of EU GMP regulations including CMP and MIA frameworks.
• Fluent German and professional proficiency in English.

Aufgaben

• Lead regulatory workstream for transfer of CMP and MIA certificates.
• Compile and submit necessary documentation for compliance.
• Track regulatory milestones and provide updates to management.

Kenntnisse

Regulatory Affairs

Problem Solving

Organizational Skills

Analytical Skills

Communication

Ausbildung

University degree in Pharmacy, Life Sciences or Regulatory Affairs

Jobbeschreibung

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia, and the Americas.

We are seeking a Regulatory Affairs Specialist with 6+ years of experience in the pharmaceutical or biotechnology industry to support a high-priority transfer project in Leverkusen . This role will focus on the regulatory processes required to transfer ownership of a GMP manufacturing plant and QC laboratory, including the transfer of the Certificate of Manufacturing Practice (CMP) and the Manufacturing and Import Authorization (MIA)

Responsibilities :

• Lead the regulatory workstream for the transfer of CMP and MIA certificates from the current license holder to the new owner.
• Compile, review, and submit the necessary documentation to ensure a smooth and compliant transfer.
• Advise internal teams on how to maintain operations under the existing license during the transition (e.g., PPQ batch execution and release strategy).
• Prevent delays by identifying and addressing potential regulatory issues early in the process.
• Ensure accurate, clear, and strategic communication with health authorities to avoid unnecessary repeat qualification activities under the new license.
• Work closely with QA, QC, Manufacturing, Legal, and other stakeholders to ensure alignment on regulatory timelines and deliverables.
• Track regulatory milestones and provide regular updates to project management and leadership teams.

Requirements :

• University degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related discipline.
• Minimum of 6 years of hands-on experience in Regulatory Affairs within the EU pharmaceutical or biotech industry.
• Strong knowledge of EU GMP regulations, including CMP and MIA frameworks.
• Proven experience managing regulatory processes and interacting with German authorities.
• Fluent German (mandatory) and professional proficiency in English (both written and spoken).
• Strong organizational, analytical, and problem-solving skills.
• Ability to manage complex timelines and deliverables with minimal supervision.

Location :

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.