Regulatory CMC Manager, Biologics, Pre Approval
Regulatory CMC Manager, Biologics, Pre Approval, Early Development, Hands on and Project Coverage, Western Switzerland
We are looking for a CMC professional who can take an active role in a small but growing R&D pharma division. Specifically the company are moving from early development to clinical phases and this person will be one of the first regulatory people to work on site. With this in mind it is a unique opportunity to be in a department at an early stage of development and to gain a lot of experience and autonomy. This is a small pharma setting; however, the company have a huge international presence and in many ways benefit from good financial backing and revenues. Hence it is in many ways the best of both worlds when it comes to small and large pharma.
Another key component to this role is that the company are growing actively this year and inevitably will need new people in RA. Because of this the career options look strong as the company will need new leaders to step up over the next 5 years. This could be you? Please contact me for a in formal discussion to go into more detail.
- Hands on input for CMC submissions, approvals and updates
- Strategic and technical coverage for EMA and FDA submissions
- Assistance with CTAs, INDs, NDAs and BLAs
- Input into other cross functional teams and therapy areas
- Close collaboration with QA
- Ideally over 3 years experience in regulatory affairs
- Specific experience for regulatory CMC in Biologics (Large molecules)
- Life Science degree
- Fluency in English
For a confidential discussion about regulatory affairs, or to apply, then send your CV to firstname.lastname@example.org or call me, Matt Beedle, Regulatory Affairs Consultant for Switzerland on +41435 080817 .For regular job updates and market information please join the Switzerland regulatory affairs linked-in group. https://www.linkedin.com/groups/4550988
I am a specialist head hunter(recruiter) for regulatory affairs in the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on the Swiss regulatory affairs market as well as ATMP(Advanced Therapeutics) and biological regulatory professionals world wide. Please refer to ch.linkedin.com/in/regulatoryaffairsswitzerland for references.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
Specialties: *Switzerland Regulatory Affairs Market with a focus on German speakers *Biologics EU wide *Module 3, e-CTD, Chemistry Manufacturing and Controls(CMC) *ATMP, ATP, AT, Advanced Therapeutics, World Wide *Recruitment at all levels including associate, manager, senior manager, associate director, director, global director, senior director and vice president. *SwissMedic candidates
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