Team Lead Regulatory Affairs managing a team of professionals at Merz Therapeutics. Ensuring compliance and optimizing regulatory processes across product lifecycles in the pharmaceutical sector.
Responsibilities
Lead a regional team, ensuring compliance, driving performance improvements, and optimizing regulatory processes.
Ensure local contributions to global submissions and timely responses to regulatory authority inquiries.
Ensure maintenance of licenses and timely milestone updates to support global regulatory reporting.
Align regional inputs with the global strategy and coordinate key regulatory authority interactions.
Assess regional risks and opportunities related to product acquisitions.
Support departmental objectives, cross-functional collaboration and continuous process improvement.
Requirements
University degree in a life science, ideally Pharmacy, Biology, Chemistry, or equivalent.
10+ years' experience at a regulatory authority or in the pharmaceutical industry with involvement in development activities.
5+ years' leadership experience in the global pharmaceutical industry and the ability to lead an international team.
Extensive knowledge of the international regulatory landscape and, ideally, regulatory experience in two regions.
Experience in project management and budget control.
Analytical and strategic thinker with a strong compliance and quality mindset.
Solution-oriented team player with strong negotiation skills.
Excellent communication skills in English; German is a plus.
Benefits
Personalized career development in a meaningful role — improving patients' quality of life.
Hybrid working model (50:50) enabling a good work–life balance.
Attractive location with good transport links, modern workspaces and an on-site company restaurant.
Global family-owned company with flat hierarchies and an open, respectful corporate culture.
Competitive compensation with comprehensive social benefits.
A range of employer-supported benefits such as WellPass, the Deutschlandticket, Corporate Benefits and JobBike.
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