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.
- 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
- 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: firstname.lastname@example.org 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