YOUR CONTRIBUTION
In the role of Team Lead Regulatory Affairs Regions (m/f/d), you contribute to the development and success of the Merz Therapeutics organization. You lead a team of 10 professionals, ensuring timely and compliant execution of regional regulatory activities across the product lifecycle. You drive process optimization and collaborate closely with affiliates, partners, and CROs. You provide regulatory expertise and actively support the development of your team. Your main responsibilities include the following activities:
- Lead a regional team, ensure compliance, drive performance, and optimize regulatory processes across licenses, budget, and organization
- Ensure local input for global submissions and timely response to authority requests in collaboration with global teams
- Ensure license maintenance and timely milestone updates to support global regulatory reporting
- Align regional input with global strategy and coordinate key authority interactions
- Assess regional risks and opportunities for product acquisitions
- Support departmental goals, collaboration, and process improvement