Global Regulatory Lead (m/w/d) New Assets

Global Regulatory Lead (m/w/d) – New Assets

Join our motivated team in Global Regulatory Affairs and grow with exciting challenges. As a Global Regulatory Lead (GRL) you are the primary interface and key strategic partner to the Global Product Team (GPT) throughout the product life cycle on New Assets and its maintenance. This will include the following activities:

Responsibilities

• Shaping regulatory strategies and submission plans related to new registrations or life‑cycle management and representing regulatory requirements worldwide.
• Creating high‑quality documentation and carrying out required registration procedures to ensure compliance with internal and regulatory requirements.
• Ensuring the necessary regulatory activities for the preparation and submission of new‑registration applications in accordance with respective national regulatory requirements (e.g., local studies).
• Leading the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products and ensuring the necessary processes are followed.
• Managing the answering of inquiries from authorities.
• Implementing necessary register‑life‑cycle‑management activities (e.g., line extensions, annual reports, post‑approval commitments, change control, renewals, import licenses, company registrations).
• Leading and coordinating regulatory projects and communicating with the respective Merz representatives, partners or consultants as key regulatory member of the assigned Global Product Team.
• Preparing and/or participating in scientific consultations with regulatory authorities worldwide in close collaboration with the respective country RAM and other regulatory functions as appropriate.
• Supporting the creation of benefit dossiers or health technology assessments, price and reimbursement applications, and due‑diligence procedures as applicable.

Qualifications

• Completed scientific studies in Pharmacy, Biology, Chemistry or a related field; a doctorate is an advantage.
• At least five years of professional experience dealing with regulatory‑affairs aspects within the pharmaceutical industry.
• Very good knowledge of regulatory laws and regulations, including GMP, compliance aspects, and CMC documents.
• Strong communication skills, including intercultural communication, and proficiency in English at least business‑fluent.
• Strong problem‑solving skills and analytical thinking ability.
• Team player with performance orientation and persistence.

Benefits

• Individual career development in a purposeful job: you improve the quality of life of our patients.
• Hybrid work model 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‑subsidised benefits such as WellPass, Deutschland‑ticket, Corporate Benefits and JobBike.

About Us

Merz Therapeutics is 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 a family‑owned, 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 commitment to relentless research and development ensures that unmet patient needs are identified and appropriate treatments are provided. You can become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: BETTER OUTCOMES FOR MORE PATIENTS .

For more information, visit Merz Therapeutics .