Team Lead, Regulatory Affairs
Merz Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Frankfurt am Main • 🇩🇪 Germany
Visit company websiteJob Level
Senior
About the role
- Lead a regional team, ensure regulatory compliance, drive performance, and optimize regulatory processes across licensing, budget and organizational structures
- Ensure local/regional input for global regulatory submissions and provide timely responses to regulatory authority requests in collaboration with global teams
- Maintain marketing authorizations/licenses and provide timely milestone updates to support global regulatory reporting
- Align regional input with global regulatory strategy and coordinate key interactions with health authorities
- Assess regional regulatory risks and opportunities related to product acquisitions
- Support departmental objectives, foster collaboration, and drive process improvements
Requirements
- University degree in the natural sciences, preferably Pharmacy, Biology, Chemistry or equivalent
- 10+ years' experience in regulatory affairs or in the pharmaceutical industry, with exposure to development activities including clinical, quality and non-clinical aspects
- 5+ years' line management experience in a global pharmaceutical environment with proven ability to lead an international team
- Comprehensive knowledge of international regulatory environments and frameworks; ideally regulatory experience in two regions
- Experience in project management and budget control
- Analytical and strategic thinker with a compliance and quality mindset
- Solution-oriented team player with strong negotiation skills
- Excellent communication skills in English; German is a plus
Benefits
- Individual career development in a meaningful role: you contribute to improving patients' quality of life
- Hybrid working model (50:50) supporting work–life balance
- Attractive location with good transport connections, modern workspaces and an on-site company restaurant
- Global family-owned business with flat hierarchies and an open, respectful corporate culture
- Competitive compensation with comprehensive social benefits
- Range of employer-subsidized benefits, including WellPass, Deutschland-Ticket, Corporate Benefits and JobBike
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceregulatory submissionsmarketing authorizationsregulatory reportingregulatory risk assessmentproject managementbudget controlanalytical thinkingstrategic thinkingnegotiation
Soft skills
leadershipcollaborationprocess improvementsolution-orientedteam playercommunicationinternational team managementperformance drivingorganizational skillscompliance mindset
Certifications
university degree in natural sciencesPharmacy degreeBiology degreeChemistry degree