Job Description
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
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Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage
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3-5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry
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Strong communication skills, also intercultural, including profound English (at least business fluent)
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Strong problem-solving skills and analytical thinking ability
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Team Player with persistence
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Individual career development in a purposeful job: you improve the quality of life of our patients!
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Hybrid work model that allows a good work-life balance
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Attractive location with good transport links, modern workplaces and a company restaurant (€4.13/menu)
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Global family business with flat hierarchies and an open, respectful corporate culture
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Attractive remuneration with extensive social benefits
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Variety of employer-subsidized benefits such as WellPass (€17.90/month), Germany ticket (10€/month), Corporate Benefits and JobBike
Find our more about our benefits here.
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