- Location
- Frankfurt am Main, Hessen, Deutschland
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Legal
Description
YOUR CONTRIBUTION
In the role of Head Regulatory Affairs Regions (m/f/d), you contribute to the development and success of the Merz Therapeutics organization. You lead a group of 17 Regional Regulatory professionals (organized in 2 Teams, e.g. one Team Lead and 8 Regional Regulatory Affairs managers report directly), 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
YOUR PROFILE
- University degree in natural sciences studies, preferrable pharmacy, biology, chemistry or equivalent
- 10+ years in regulatory affairs or in the pharmaceutical industry exposed to developmental activities involving clinical, quality and non-clinical tasks
- 5+ years of line management experience in a global pharmaceutical industry and the ability to lead an international team
- Comprehensive knowledge of international regulatory environment and frameworks and ideally regional regulatory experience for 2 regions
- Experienced in project management and budget control
- Analytical and strategic thinker with compliancy & quality mindset
- Solution oriented team player paired with strong negotiation skills
- Excellent communication skills in English, German is a plus
YOUR BENEFIT
- Individual career development in a purposeful job: you improve the quality of life of our patients!
- Global family business with flat hierarchies and an open, respectful corporate culture
- Hybrid work model that allows a good work-life balance
- Attractive location with good transport links, modern workplaces and a company restaurant
- Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike
ABOUT US
Welcome to Merz Therapeutics, a global leader in specialty neurology, delivering innovative treatments that help people with movement disorders, neurodegenerative conditions, liver disease, and other serious health challenges regain their quality of life.
We are proud to be a family-owned company with over 117 years of heritage. Our therapies reach patients in more than 80 countries, driven by a passion for innovation and a commitment to growth.
Our goal is to address urgent, unmet medical needs—investing in research, expanding our portfolio, and empowering people to live better lives.
Join our international Merz Therapeutics family and help us achieve our mission:
"BETTER OUTCOMES FOR MORE PATIENTS"
