Overview
In this role you will provide regional regulatory support across EU/UK/CH to enable regulatory approvals and lifecycle management of our drugs. You will work with cross-functional teams to prepare dossiers, manage submissions, and implement local changes in product information. You will shape regional regulatory strategy, handle authority interactions, and ensure compliance to accelerate patient access. This is a pivotal role in our mission to improve patient outcomes through robust regulatory execution.
Leistungen / Benefits
- Hybrid work model
- Good transport links and modern workplaces
- Company restaurant
- Flat hierarchies and respectful culture
- Attractive remuneration and social benefits
- WellPass and Deutschland-Ticket
Verantwortungsbereiche
- Dossier preparation for EU/UK/CH region to ensure compliance with internal and international standards
- Coordinate and submit Marketing Authorization applications and GMP verifications
- Implement local regulatory changes and update product information texts and packaging
- Manage lifecycle activities including renewals, variations, and post-approval commitments
- Handle deficiency letters from regulatory authorities with timely responses
- Coordinate with global teams, local partners, and third-party providers on regulatory needs
- Contribute to regulatory strategy and stay updated on regional requirements
- Prepare for and participate in meetings with regulatory authorities with local and global stakeholders
Zentrale Anforderungen
- Completed scientific studies in Pharmacy, Biology, Chemistry or related field
- 3-5 years of regulatory affairs experience in EU/UK/CH with centralized procedure exposure
- Strong communication skills, including fluent English
- Strong problem-solving and analytical thinking
- Team player with persistence
- Strong communication, intercultural awareness
- problem-solving
- team collaboration
- Regulatory affairs in EU/UK/CH
- Centralized procedure experience
- Dossier preparation and submissions
Regional Regulatory Affairs Manager (m/f/d) EU/UK/CH in Wiesbaden Arbeitgeber: Merz Pharma
Merz Therapeutics ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur eine sinnstiftende Tätigkeit im Bereich Datenschutz bietet, sondern auch individuelle Karriereentwicklung in einem wertschätzenden und familiengeführten Umfeld fördert. Mit einem hybriden Arbeitsmodell, attraktiven Sozialleistungen und einem modernen Arbeitsplatz in Frankfurt am Main sorgt das Unternehmen für eine ausgewogene Work-Life-Balance und unterstützt aktiv die persönliche und berufliche Weiterentwicklung seiner Mitarbeiter.
