Head of Regulatory Affairs (m/f/d).
Job ID: 11448
Discipline
Regulatory Affairs
Type of employment
Festanstellung
Responsibilities
- Responsibility and representation of the company for all issues in the area of admission as a member of the management team (report to the management)
- Development and implementation of regulatory strategies
- Coordination and preparation of new registration applications (EU, national) and processing of deficiency letters
- Care and maintenance of existing approvals
- Support and strategic consulting for international clients in the context of marketing authorization procedures and in the maintenance of existing marketing authorizations (Europe, Asia, South America)
- Scientific Advice with authorities (Scientific Advice)
- Preparation and review of pharmaceutical quality documentation
- Review, interpretation and follow-up of legal requirements and guidelines
- Management of the staff of the Admissions Department
- Close cooperation with the development, quality control, manufacturing, quality assurance and business development departments as well as appropriate project coordination. Cooperation with external suppliers (e.g. active ingredient)
Requirements
- Natural scientists with several years of professional experience in drug regulatory affairs
- Initial management experience
- Extensive expertise in the European (incl. German) regulatory environment and experience with the relevant approval procedures (e.g. NTA, CTD, EMA, EU, ICH guidelines, European Pharmacopoeia; basic knowledge of GMP)
- Independent, goal-oriented, cross-functional and structured way of working
- Confident manner and very good written and spoken German and English skills
- High level of commitment, initiative and enthusiasm
Region
Süd