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Senior Regulatory Affairs Manager/Lead, Biotech

Employer
NonStop Consulting
Location
Lugano
Salary
£47118 - £70677 per annum
Closing date
Sep 13, 2017

View more

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

Job Details

Senior Regulatory Affairs Manager/Lead, Biologics

We are currently looking to help build up a team for an up and coming biotech. The company have a number of critical approvals coming up and in addition to this, a healthy portfolio of products in early clinical phases. As such, we are looking for someone with strong EU/FDA regulatory experience who can lead approvals from clinical to late phase for biologicals (large molecules). The role reports to the head of regulatory and will work closely with the VP of supply chain and business development on the site. If you could be interested 'in principle', then please contact me.

Responsibilities:

  • Take a lead role on certain products for regulatory submissions
  • Coverage of CMC, IMPDs and CTA fillings
  • Collaboration on scientific advice and regulatory meetings with EMA and FDA
  • Management of associates, CROs and consultants

Basic Requirements:

  • Experience in regulatory submissions for large molecule pharmaceuticals
  • Experience in regulatory development
  • Fluency in English
  • Over 6 years experience overall in regulatory affairs for Pharma
  • Life science degree

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 +41 43 50 80 817 . Please feel free to check my linked-in account for my references.

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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