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

Merz Therapeutics; Frankfurt; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company in Frankfurt seeks a Global Regulatory Lead to shape regulatory strategies and manage compliance for new product registrations. With at least 5 years of experience in regulatory affairs, the ideal candidate will create essential documentation and coordinate projects within a global team. This role promotes work-life balance through a hybrid model, offers competitive remuneration, and supports individual career growth in a meaningful job focused on patient care.

Leistungen

Hybrid work model

Attractive remuneration

Employer-subsidized benefits

Modern workplaces

Company restaurant

Qualifikationen

• 5+ years of experience in regulatory affairs within the pharmaceutical industry.
• Very good knowledge of regulatory laws and GMP compliance.
• Strong intercultural communication skills, proficient in English.

Aufgaben

• Shape regulatory strategies and submission plans for new registrations.
• Create high-quality documentation for registration procedures.
• Lead and coordinate regulatory projects as part of the Global Product Team.

Kenntnisse

Regulatory knowledge

Communication skills

Problem-solving

Analytical thinking

Ausbildung

Completed scientific studies in Pharmacy, Biology, Chemistry or related field

Doctorate (advantage)

Jobbeschreibung

YOUR CONTRIBUTION

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

• Shaping regulatory strategies and submission plans related to new registrations or life cycle management and representing regulatory requirements worldwide
• Creating high-quality documentation and carry out required registration procedures ensuring compliance and internal requirements
• Ensuring and implementation of the necessary regulatory activities for the preparation and submission of applications for new registrations in accordance with the respective national regulatory requirements (e.g. local studies)
• Leading the creation and maintenance of the Company Core Data Sheet (CCDS) for the assigned products as well as ensuring the necessary processes are followed
• Ensuring and managing the answering of inquiries from the authorities
• Implementation of necessary regulatory 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 as well as communication with the respective Merz representatives, partners or consultants as key regulatory member of the assigned Global Product Team (GPT)
• Preparation and/or participation in scientific consultation with the regulatory authorities worldwide in close collaboration with the respective country RAM and other regulatory functions as appropriate
• Support in the creation of benefit dossiers or health technology assessments, price and reimbursement applications, as well as due diligence procedures as applicable

YOUR PROFILE

• Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage
• At least 5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry
• Very good knowledge of regulatory laws and regulations, including GMP and compliance aspects as well as CMC documents
• Strong communication skills, also intercultural, including profound English (at least business fluent)
• Strong problem-solving skills and analytical thinking ability
• Team Player with performance orientation and persistence

YOUR 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-subsidized benefits such as WellPass, Deutschland-ticket, Corporate Benefits and JobBike

Find our more about our benefits here.

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 commitment to 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".

For more information, visit https://www.merztherapeutics.com/.