Senior Regulatory Affairs Dossier Development and Operations

Are you looking for a challenging job in regulatory affairs? Do you have experience with Module 3 dossier development? This can be the right job for you! In this position you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You will ...
Leiden | CLS Services | 2019-04-16
R&D/Science WO / MBA Fulltime Vast dienstverband Midcareer (ervaren)

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Vaccines & Prevention</STRONG>, we are searching for a Senior Regulatory Affairs Dossier Development and Operations.

Company profile
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.



Job description
Are you looking for a challenging job in regulatory affairs? Do you have experience with Module 3 dossier development? This can be the right job for you!

In this position you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You will coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. You coordinate the timeline, virtual documents and generation of the Quality module. You will represent the department on multi-functional project development teams to support regulatory filings.
Other responsibilities:



Who we're looking for
The ideal candidate has a PhD with PostDoc and at least 3 years of relevant experience in regulatory. University degree with at least 6 years of relevant experience will also be considered. You have experience with Module 3 Dossier Development for premarketing INDs/IMPDs or MAA/BLA. Additionally you have experience with late stage development.

Additional vacancy information
Reference: A1900060
Contract: Temporary contract with CLS Services
Education: PhD.
WO/MSc.
Terms: Project for at least 8 months. Longer term possibilities anticipated. Full time strongly preferred, 32 hours discussable. Flexible on location though commitment expected to come to Leiden 1-2 days per week.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555