Technical Regulatory Affairs Manager
Technical Regulatory Affairs Manager - Basel
Jasmin Baumgartner is recruiting for a Technical Regulatory Affairs Manager to join a company in the drug discovery industry at their site based in Basel on a contract basis for between 6 to 12 months.The main purpose of the role will be to:
- Write and update the Module 2 (Quality Overall Summary) and the Module 3 (drug substance and drug product quality sections) of the CTD/NDA Applications.
- Write and update the Quality part of the IMPD/INDs for clinical trials applications (Entry to Man, up to Phase III studies).
- Support and advise the project team regarding pharmaceutical development related to regulatory strategy for submission.
Further responsibilities will include:
- Preparing the answers to the CMC questions raised by the Health Authorities following the submission of Marketing/Clinical Trial Applications and technical variations.
- Creating Briefing Books and supportive documentation for Health Authority meetings (pre-IND, pre-NDA, End of Phase II, Scientific Advice meetings).
- Attending Health Authority meetings to discuss pharmaceutical development related to regulatory strategy for submission.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Pharmacist (PharmD) or University degree (MSc, PhD) in Chemistry or Biology.
- Knowledge of, and understanding of ICH guidelines (Quality).
- Prior experience in technical regulatory affairs (CMC writer of Quality sections of IND/IMPD/NDA/CTDs).
This is an exciting opportunity to join a growing and global company.
For more information or to apply for this position, please contact Jasmin Baumgartner on +41 (0) 782 508 535 or email firstname.lastname@example.org. Please quote reference 46579 in all correspondence.