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Job Details
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Senior Regulatory CMC Manager, Pre Approval



Business Type: Pharmaceutical Company
Job Type: Regulatory Affairs
Job Level: Management
Position: Full Time
Salary: CHF130000 - CHF160000 per annum + Negotiable
Location: Switzerland
Reference: MB/8480783/9/84
Closing Date: 12/11/18
Background:

Senior 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 is moving from more early development to clinical phases and this person will be actively involved in many key products. 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 has 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 is 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 an in formal discussion to go into more detail.

Role Responsibilities:

  • 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

Role Requirements:

  • Ideally over 5 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 m.beedle@nonstop-recruitment.com 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

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.



NonStop Recruitment Posted by:: NonStop Recruitment (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 05/11/2018 | NPJ Ref: 224923
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