Regulatory Affairs Manager Jobs

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our Regulatory Affairs (RA) team, we are looking for a (Senior) Regulatory Affairs Manager (permanent position, 100%, f/m/d).

You will take full responsibility for your assigned projects/tasks while benefiting from working within a highly motivated and innovative team.

Your tasks

• Representation of RA in projects, including discussions and negotiations with the customers during the whole product lifecycle, i.e, from pre-clinical to marketed.
• Close cross-functional collaboration with a high diversity of internal stakeholders.
• Development and tailoring of convincing regulatory strategies.
• Delivery of regulatory advice to internal and external stakeholders.
• Hands-on writing and review of regulatory documents and dossiers in accordance with customer requirements and applicable regulatory rules and guidelines. The documents may have different backgrounds, e.g.,
• Life-cycle phase from clinical Phases I-III or market purpose (e.g., NDA)
• Peptide and oligonucleotide APIs
• Target markets, e.g., US, EU, JP, CN, BR
• Coordination of responses to authority requests in close collaboration with our customers.
• Steering of site-overarching initiatives for improvement and innovation while proactively anticipating challenging situations.
• Management of internal and external stakeholders to reach regulatory objectives while demonstrating high degree of integrity, reliability, resilience, tenacity, openness and collaborative spirit.
• Coaching other RA members, as well as actively contributing to the knowledge-building and -transfer within the team.

Your profile

• University degree Master and/or PhD with focus on Natural Sciences (Chemistry, Pharmacy, or similar field).
• At least 5 years of professional experience in an RA function. Experience with regulatory requirements for drug substances is a plus.
• Strong communication and collaboration skills supporting successful and efficient exchange with internal stakeholders, customers, and regulatory agencies based on a business mindset.
• Experience in supervising complex projects and tasks and in establishing regulatory strategies.
• Flair for creating high-quality output ranging from convincing presentations to on-point drug substance CMC sections of regulatory dossiers.
• Critical thinker with a lot of curiosity and a knack for creative solutions.
• Fluent and persuasive in English (C1) – German as a plus.

Our offer:

• An empowered key position in an exciting, challenging, and highly dynamic environment that guarantees a wide range of activities.
• You will join a team of international specialists that will help nurture your professional growth.
• Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction.
• Employee development through internal and external training opportunities.
• Modern terms of employment and attractive fringe benefits.

Interested?

We look forward to receiving your complete application package (e.g., motivation letter, CV, testimonials, diploma) online via our Application Portal.