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Global Regulatory Affairs CMC

2019-03-12 CLS Services | Leiden | WO / MBA | Fulltime | Sluit 2019-05-11

As a member of the Global Regulatory Affairs CMC team, you will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. Your primary responsibility is to support the regulatory activities related to vaccines in Europe and US, ...

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, Janssen Biologics B.V., we are searching for a Global Regulatory Affairs CMC.

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.



Job description
As a member of the Global Regulatory Affairs CMC team, you will contribute to the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans. Your primary responsibility is to support the regulatory activities related to vaccines in Europe and US, and specifically to support the preparation of a MAA and BLA. You will support CMC Teams and provide direction on the interpretation and application of CMC regulations and guidances related to vaccines. Additional responsibilities include: contribute to the preparation and editing of clinical trial applications that include vaccines.

Who we're looking for
We are looking for a candidate with a MSc degree in biological, pharmaceutical, or chemical sciences and at least 5 years of experience in CMC-Regulatory Affairs. Strong knowledge of vaccines and EU and FDA regulations is required. You have significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs. Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.


Additional vacancy information
Reference: A1900038
Contract: Temporary contract with CLS Services
Education: WO/MSc.
Terms: Full time preferred, 32 hours discussable. Location flexible, however must be in Leiden 1x per week minimal, and flexible to come 3-4 days in first 2~ months during training.
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555



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