Regional Regulatory Affairs Manager (m/f/d) APACMEA

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 APACMEA.

• Dossier Preparation: Develop and maintain high-quality regulatory documentation for APACMEA 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; a doctorate is an advantage
• 3‑5 years of professional experience dealing with regulatory affairs aspects in the region APACMEA and specifically the centralized procedure 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