Manager Regulatory Affairs

Manager Regulatory Affairs

Bachem

Bubendorf, Switzerland

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.