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

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

Zusammenfassung

A leading pharmaceutical company in Frankfurt is seeking a Team Lead in Regulatory Affairs to guide a team of 10 professionals. The role requires over 10 years of experience in regulatory affairs, including management experience. The ideal candidate will have a strong understanding of the regulatory landscape and be an effective communicator. This position offers a hybrid work model and a focus on improving patient outcomes.

Leistungen

Individual career development

Hybrid work model

Attractive location with good transport links

Company restaurant

Attractive remuneration with extensive social benefits

Employer-subsidized benefits such as WellPass and JobBike

Qualifikationen

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

Aufgaben

• Lead a regional team and ensure compliance with regulatory processes.
• Collaborate on global submissions and respond to authority requests.
• Assist in product acquisitions by assessing regional risks.

Kenntnisse

Regulatory affairs expertise

Project management

Analytical thinking

Negotiation skills

Communication skills in English

German language skills

Ausbildung

University degree in natural sciences

Jobbeschreibung

YOUR CONTRIBUTION

In the role ofTeam 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 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 region
• 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!
• Hybrid work model (50:50) that allows a good 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 corporate culture
• Attractive remuneration with extensive social benefits
• Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike

ABOUT US

Welcome to Merz Therapeutics, a leading pharmaceutical company that helps 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 and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries.

Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings.

Our dedication and commitmentto relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided.

Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal:

" BETTER OUTCOMES FOR MORE PATIENTS"