Team Lead Regulatory Affairs Regions (m/f/d)

Merz Therapeutics; Deutschland; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Germany is looking for a Team Lead Regulatory Affairs Regions. This role involves leading a team of 10 to ensure compliance and optimize regulatory processes across product lifecycles. The ideal candidate will have over 10 years of regulatory experience in the pharmaceutical industry and strong leadership skills. Benefits include a hybrid work model, career development opportunities, and attractive remuneration.

Leistungen

Individual career development

Hybrid work model

Modern workplaces

Employer-subsidized benefits

Qualifikationen

• 10+ years in regulatory affairs or pharmaceutical industry experience.
• 5+ years of line management experience in a global pharmaceutical environment.
• Comprehensive knowledge of international regulatory frameworks.

Aufgaben

• Lead a regional team to ensure compliance and optimize regulatory processes.
• Ensure local input for global submissions and timely responses to authority requests.
• Align regional input with global strategy and coordinate authority interactions.

Kenntnisse

Leadership

Regulatory knowledge

Project management

Strategic thinking

Negotiation skills

Analytical skills

Communication

Ausbildung

University degree in natural sciences (pharmacy, biology, chemistry)

Jobbeschreibung

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

YOUR PROFILE

• University degree in natural sciences, preferably pharmacy, biology, chemistry, or equivalent
• 10+ years in regulatory affairs or the pharmaceutical industry, involving clinical, quality, and non-clinical tasks
• 5+ years of line management experience in a global pharmaceutical industry with the ability to lead an international team
• Comprehensive knowledge of international regulatory environments and frameworks, with regional regulatory experience in at least 2 regions
• Experience in project management and budget control
• Analytical and strategic thinker with a compliance & quality mindset
• Solution-oriented team player with strong negotiation skills
• Excellent communication skills in English; German is a plus

YOUR BENEFITS

• Individual career development in a purposeful job: improve the quality of life for patients
• Hybrid work model (50:50) supporting work-life balance
• Attractive location with good transport links, modern workplaces, and a company restaurant
• Global family business with flat hierarchies and an open, respectful culture
• Attractive remuneration with extensive social benefits
• Employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits, and JobBike

ABOUT US

Welcome to Merz Therapeutics, a leading pharmaceutical company dedicated to helping people with movement disorders, neurological diseases, liver diseases, and other health conditions regain their quality of life.

We are proud to be a family-owned, value-driven company with 110 years of history, now a global innovation leader with products in over 90 countries.

Our goal is to improve treatment outcomes worldwide, reducing the burden of suffering for affected individuals and their communities.

Our commitment to relentless research and development ensures unmet patient needs are identified and addressed with appropriate treatments.

Join our international and motivated Merz Therapeutics family to help us achieve:

"BETTER OUTCOMES FOR MORE PATIENTS"

Viktoria Becker
Talent Acquisition Partner