Regulatory Affairs Manager
Categorie: Regulatory Affairs
Novellas Healthcare is looking for a Regulatory Affairs Manager. Prefered you work on freelance basis (permanent contract is definitely an option).
You will report to the Director Regulatory Affairs.
- Preparation and follow-up of global CTA and IND submissions, including responses to Authorities and Ethics Committees
- Execute oversight on CRO regulatory activities with respect to clinical trial authorisations
- Tracking of and reporting on CTA/IND submission and approval status
- Maintenance of public study and study results registries such as clinicaltrials.gov and EudraCT
- Preparation and follow-up of Scientific Advice/Protocol Assistance procedures
- Preparation and follow-up of Orphan Drug Designation submissions for EMA or FDA
- Preparation and follow-up of Paediatric Investigation Plan submissions
- Contribute to development of processes, including preparation of standard operating procedures
- Follow (changes of) regulatory legislation and guidances globally
- Bachelor or Master degree (Medical, Pharmaceutics, Biomedical Sciences)
- 5-10 years of relevant experience in (clinical) Research and Development within the pharmaceutical or biopharmaceutical industry
- Knowledge of regulatory environment for clinical trials in EU, US and other regions
- Scientific background allowing contribution to regulatory processes and documents on content level
- Excellent knowledge of English (spoken/written)
Excellent rganizational and planning skills
Novellas Healthcare offers you a job in a dynamic work environment and a competitive remuneration package according to your experience.
Novellas Healthcare is a company with over 10 years of experience in people-related services for the healthcare sector. Our goal is to maximize people’s careers in healthcare, and our customer’s human capital. We provide Permanent and Flexible Staffing Solutions, Training & Coaching and Patient Programs.Back to overview