Head of Regulatory Affairs
A leading biotechnology company focused on the development of drugs for the treatment of chronic infections, is currently recruiting for a Head of Regulatory Affairs. Based at their company's office in Germany, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Developing in-house regulatory expertise, including the establishment and growth of a Regulatory Affairs department.
- Responsible for the development of regulatory strategies for new products in clinical development as well as the preparation and filing of NDA/ MAA & IND/CTA.
- Leading regulatory activities of external contractors and consultants.
- Providing regulatory input for clinical study protocols, case report forms, clinical study reports, informed consent forms and other documents.
- Development of regional and global regulatory strategies with country-specific requirements.
- Providing regulatory leadership in due diligence and early development projects.
Skills and Requirements:
- 5+ years' of experience in Regulatory Affairs (Biotech, Pharmaceutical or CRO background all considered).
- Experience in leading internal teams regulatory in matrix organisations and in leading external CRO activities.
- Proven leadership of submissions to EMA, FDA and other major regulatory authorities.
- Proven leadership of regulatory activities for the commercial launch of new products.
- Regulatory experience in due diligence both of early opportunities and products in late development.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Nico Kohlwes at email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.