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Regulatory CMC Manager, Biologics, Pre Approval

Employer
NonStop Consulting
Location
Genève
Salary
£69354 - £84766 per annum + Negotiable
Closing date
Jan 29, 2018

View more

Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice
Jobseeker Type
Professional

Job Details

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 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 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 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 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.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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