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Regulatory Affairs Senior Manager

Swisslinx Zug, Schweiz
Gepostet vor 20 Tagen Befristet Competitive
Regulatory Affairs Senior Manager
Our client, a leading biotechnological company based in the area of Zug is searching for a Regulatory Affairs Specialist on Clinical Trials to join their team.

We are offering a one year contract with a high possibility of extension to work in an internationally reputable biotechnological company in the industry with great working environment.

Your mission:

- Responsible for defining the company's Biosimilar regulatory strategies for assigned projects and programs and for obtaining project team alignment on those strategies

- Act as the regulatory representative with strategic partners for assigned projects and programs and responsible for securing partner alignment on regulatory strategy

- Responsible for the development of core aRMMs and for leading their customisation, submission, approval and dissemination across markets

- Define the company's Biosimilar labelling strategy, taking into account commercial and medical drivers

- Discuss and align regulatory CMC strategies internally and facilitate alignment as needed

Your background:

- BSc; MSc or Ph.D. in a life sciences discipline

- At least 6 years of experience in the pharmaceutical or biotechnological industry with at least 4 of them in the field of regulatory affairs

- Knowledge of the European drug development process and regulatory requirements

- Fluent in English

What's on offer?

Our client offers an exciting position in a positive and collaborative environment. Does this description sound like you? If so, please get in touch, and you could be embarking on a new and exciting professional opportunity.

For further information or to apply, please contact Asher Cos, recruiter: asher.cos@swisslinx.com
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA

I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
Job ID  14680
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