Regional Regulatory Affairs Manager (m / f / d)

Merz Therapeutics; Frankfurt; Vor Ort; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Regional Regulatory Affairs Manager to ensure compliance and support drug development in a dynamic environment. This role involves preparing regulatory documentation, managing submissions, and collaborating with global teams to navigate the complexities of regulatory requirements. You will play a crucial role in life-cycle management and agency interactions, contributing to the strategic direction of the company. Join a global family business that values innovation and offers a hybrid work model, allowing you to balance professional growth with personal well-being, while making a meaningful impact on patients' lives.

Leistungen

Hybrid work model

Attractive remuneration

Extensive social benefits

Employer-subsidized benefits

Modern workplaces

Company restaurant

Good transport links

Qualifikationen

• 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
• Completed scientific studies in a relevant field; doctorate is an advantage.

Aufgaben

• Prepare high-quality regulatory documentation and manage submissions.
• Coordinate with teams for regulatory life-cycle activities and compliance.

Kenntnisse

Regulatory Affairs

Communication Skills

Problem-Solving Skills

Analytical Thinking

Intercultural Communication

Ausbildung

PhD in Pharmacy, Biology, or Chemistry

Bachelor's or Master's in related field

Jobbeschreibung

Regional Regulatory Affairs Manager (m / f / d)

Full Time

• With Professional Experience
• 3 / 5 / 25

YOUR CONTRIBUTION

As a Regional Regulatory Affairs Manager (m / f / d), you will provide regional regulatory support for the strategic development, approval, and life cycle management of drugs, ensuring compliance with regulatory and legal requirements in the assigned region. This will include the following activities:

• Dossier Preparation: Develop and maintain high-quality regulatory documentation for assigned regions, ensuring compliance with internal and international standards.
• Marketing Authorization: Coordinate and submit applications for new registrations, approvals, and GMP verifications, adhering to national regulatory requirements.
• Change Control & Product Information: Implement local regulatory changes and update product information texts and packaging in line with company and national standards.
• Life-Cycle Management: Manage regulatory life-cycle activities, including renewals, variations, and post-approval commitments, in collaboration with internal and local teams.
• Response Management: Handle deficiency letters from regulatory authorities, ensuring timely and accurate responses.
• Project Coordination: Communicate regional regulatory needs to global teams, coordinate with local partners, and manage third-party service providers.
• Regulatory Strategy & Intelligence: Contribute to regulatory strategies and stay updated on regional regulatory requirements and best practices.
• Agency Interactions: Prepare for and participate in meetings with regulatory authorities, collaborating with local and global stakeholders.

YOUR PROFILE

Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field of studies; a doctorate is an advantage.

3-5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry.

Strong communication skills, also intercultural, including profound English (at least business fluent).

Strong problem-solving skills and analytical thinking ability.

Team player with 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.

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".

Viktoria Becker, Talent Acquisition Partner