Overview
As a Regional Regulatory Affairs Manager, you will provide regulatory support for APACMEA across development, approval, and lifecycle activities. You’ll coordinate submissions, manage changes, and liaise with authorities and partners to ensure compliant product information and packaging. You will shape regulatory strategies and align regional needs with global teams, enabling timely market access and lifecycle management. This role offers impact in patient outcomes and cross-functional collaboration in a global family business.
Leistungen / Benefits
- Hybrid work model
- Good transport links and modern workplaces
- Company restaurant
- Flat hierarchies and open culture
- Extensive social benefits
- WellPass, Deutschland-Ticket, Corporate Benefits, JobBike
Verantwortungsbereiche
- Dossier preparation for APACMEA regulatory documentation
- Coordinate and submit regulatory applications and GMP verifications
- Implement local regulatory changes and update product information and packaging
- Manage lifecycle activities (renewals, variations, post-approval commitments)
- Handle deficiency letters and provide timely responses
- Coordinate regional regulatory needs with global teams and local partners
- Contribute to regulatory strategy and stay updated on regional requirements
- Prepare for and participate in agency meetings with regulatory authorities
Zentrale Anforderungen
- 3-5 years of regulatory affairs experience in APACMEA with centralized procedure exposure
- Completed scientific studies in Pharmacy, Biology, Chemistry or related field (doctorate an advantage)
- Strong communication skills, especially English (business fluent)
- Strong problem-solving and analytical thinking
- Team player with persistence
- intercultural communication
- team collaboration
- problem-solving
- regulatory submissions (APACMEA)
- lifecycle management (renewals, variations)
- regulatory strategy and intelligence
Regional Regulatory Affairs Manager (m/f/d) APACMEA 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.
