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Regulatory Affairs Specialist
vor 2 Monaten
Job Summary
We are seeking a highly skilled Global Regulatory Lead to join our team at Merz Therapeutics. As a key member of our Global Product Team, you will be responsible for shaping regulatory strategies and submission plans related to new registrations or life cycle management.
Key Responsibilities
- Develop and implement regulatory strategies to ensure compliance with national and international regulations
- Collaborate with cross-functional teams to create high-quality documentation and registration procedures
- Ensure timely and accurate submission of applications to regulatory authorities
- Lead the creation and maintenance of the Company Core Data Sheet (CCDS) for assigned products
- Manage and respond to inquiries from regulatory authorities
- Implement regulatory life cycle management activities, including line extensions, annual reports, and post-approval commitments
- Coordinate regulatory projects and communicate with Merz representatives, partners, or consultants
- Participate in scientific consultations with regulatory authorities worldwide
- Support the creation of benefit dossiers, health technology assessments, and due diligence procedures
Requirements
- Completed scientific studies in Pharmacy, Biology, Chemistry, or a related field; a doctorate is an advantage
- At least 5 years of professional experience in regulatory affairs within the pharmaceutical industry
- Strong knowledge of regulatory laws and regulations, including GMP and compliance aspects
- Excellent communication and problem-solving skills, including intercultural communication
- Team player with performance orientation and persistence
What We Offer
- Individual career development in a purposeful job
- Hybrid work model with a good work-life balance
- Attractive location with good transport links and modern workplaces
- Global family business with flat hierarchies and an open, respectful corporate culture
- Attractive remuneration with extensive social benefits
- Variety of employer-subsidized benefits
