Manager Regulatory Affairs 100% (f/m/d)
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.