Senior Regulatory Affairs Specialist

Werkgever CLS Services
Plaats Leiden
Provincie Zuid-Holland
Land Nederland
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum donderdag 11 oktober 2018

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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 Senior Regulatory Affairs Specialist.

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
We are looking for a experienced regulatory affairs specialist who can support all regulatory activities associated with the development, post-approval and life-cycle management for designated products within the Oncology portfolio. You interact with project teams, LOCs, regulatory agencies and supporting submissions to provide regulatory content support for products. You guide and support product development teams on regulatory issues.
Do you have knowledge of how Health Authorities (HA) operate and a good general knowledge of HA organisational structure and individual responsibilities in those structures? Please apply for this vacancy!

Who we're looking for
We are looking for a candidate with a background in Life Sciences and at least 5 - 8 years of experience in European and/or global regulatory affairs. You have proven experience with full product life-cycle and regulatory strategies. You know how to work with clinical trial programmes and CTA procedures. You have business development skill sets with exposure to or having worked in a regulatory consultancy model.
Are you the creative and excellent communicator we are looking for?

Additional vacancy information
Contract:Temporary contract with CLS Services
Education:HBO/BSc. WO/MSc. PhD.
Employment terms:Full time applicants only. Fixed term assignment for 6 months (maternity leave cover), extension possibilities currently not anticipated, but will be reviewed nearer the end of the assignment.
Contactperson:Aniek Vugts
+31 (0)31 (0)88 22 77 555


Opleiding Gepromoveerd
Ervaring Ervaren (3 - 8 jaar)


Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (Please use button *Direct solliciteren*)
(Vacancy number A1800101)
You can follow our vacancies on Twitter .

For more information please contact Aniek Vugts at +31 (0)31 (0)88 22 77 555


As a dynamic company CLS Services is dedicated to recruiting top level professionals in chemistry and life sciences. Clients appreciate our professionalism, flexibility and ability to come up with tailor-made solutions for any specialist function. Founders and directors Jan Paul Favier and René Kemps both have relevant technical backgrounds and extensive experience in high-level recruitment in the CLS Services sector. In short time we have built up an impressive track record and now serve multinationals as well as smaller and more specialized biotech, chemical, pharmaceutical and food companies.

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