Regulatory Affairs Leadership Expert
Vor 4 Tagen
Arevipharma GmbH seeks a seasoned Head of Regulatory Affairs to lead our Regulatory Affairs team. This key role oversees all regulatory processes, ensuring compliance with applicable standards and driving continuous improvement initiatives within the department.
About the Role
This is a leadership position that requires experience in team management, with a focus on leading regulatory projects, consolidating data from various departments to produce regulatory reports and dossier sections. The ideal candidate will have a deep understanding of drug regulatory affairs and be proficient in English and German (fluency required).
Salary
The estimated salary for this position is €80,000 - €110,000 per year, commensurate with experience. Benefits include various tax-advantaged offerings, such as contributions towards childcare costs, and free beverages.
Responsibilities
- Lead all regulatory processes and ensure compliance with applicable standards
- Drive continuous improvement, optimization, and digitalization initiatives within the Regulatory Affairs department
- Independently manage regulatory projects, consolidating data from various departments to produce regulatory reports and dossier sections
- Prepare and update active substance dossiers (including QOS)
Qualifications
- Completed university degree (preferably as a pharmacist or chemist), ideally with a Ph.D. and a Master's in Drug Regulatory Affairs
- Minimum of 5 years of experience in Drug Regulatory Affairs
- Demonstrated experience in team and personnel management
- Proficient in English and German (fluency required); additional languages such as French or Spanish are an advantage
Benefits
- Finanzielle Unterstützung: Various tax-advantaged offerings and contributions towards childcare costs
- Getränke: Free beverages
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