Regional Regulatory Affairs Manager (mfd)

Frankfurt - Germany

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 region APAC-MEA. This will include the following activities:

Dossier Preparation: Develop and maintain high-quality regulatory documentation for responsible region 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 in the region APAC-MEA and specifically the centralized procedure within the pharmaceutical industry
Strong problem-solving skills and analytical thinking ability
Team Player with persistence
Strong communication skills also intercultural including profound English (at least business fluent)

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 Therapeuticsa leading pharmaceutical company that helps people with movement disorders neurological diseases liver diseases and other health conditions regain their quality of life.

We are proudto 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 goalis 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

For more information visit Experience:

Unclear Seniority

YOUR CONTRIBUTIONAs 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 region APAC-MEA. This will include the following ...