Manager Regulatory Affairs

Manager Regulatory Affairs

Bachem

Bubendorf, Switzerland

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.