Regulatory Affairs Specialist
vor 2 Monaten
At Merz Therapeutics, we are seeking a highly skilled Regional Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory and legal requirements in the assigned region.
Key Responsibilities:
- Develop and maintain high-quality regulatory documentation for assigned regions, ensuring compliance with internal and international standards.
- Coordinate and submit applications for new registrations, approvals, and GMP verifications, adhering to national regulatory requirements.
- Implement local regulatory changes and update product information texts and packaging in line with company and national standards.
- Manage regulatory life-cycle activities, including renewals, variations, and post-approval commitments, in collaboration with internal and local teams.
- Handle deficiency letters from regulatory authorities, ensuring timely and accurate responses.
- Communicate regional regulatory needs to global teams, coordinate with local partners, and manage third-party service providers.
- Contribute to regulatory strategies and stay updated on regional regulatory requirements and best practices.
- Prepare for and participate in meetings with regulatory authorities, collaborating with local and global stakeholders.
Requirements:
- 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.
What We Offer:
- 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, Germany ticket, Corporate Benefits, and JobBike.
Join us in our mission to improve treatment outcomes for patients around the world and become part of our international and motivated Merz Therapeutics family.
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