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Senior CMC Regulatory Manager

Employer
NonStop Consulting
Location
Washington
Salary
Negotiable
Closing date
Jul 18, 2019

View more

Sector
Science, Life Sciences, Cell and Molecular Biology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate

Job Details

NonStop Consulting is currently working with a Global Pharmaceutical company; looking to hire an expert Senior CMC Manager within the field of Biosimilars.

In this position you will manage CMC regulatory activities in accordance with authorities and regulations.

Although the company is a well established Global Health care company, the field of Biosimilars is a relatively new venture for them. This is an opportunity to get the best of worlds between start up culture and also a well known, stable business.

Based in Washington DC, this will essentially become the flagship for CMC Regulatory Strategy putting the successful CMC Regulatory Manager in great standing to role out a global strategy.

Main Activities:

  • Provides global leadership regarding management of submission CMC related documents, CMC regulatory data and archiving for Biosimilars.
  • Act as Business partner to the Biosimilar CMC team develops, supervises and manages the CMC regulatory activities and CMC submission strategy of Biosimilar dossiers and submissions that best serve the biosimilars business needs and ensure compliance with the regulatory systems.

Key Requirement

  • Degree in a Life Science or related discipline and possible higher degree
  • At least 10 years pharmaceutical experience of which at least 8 years in international regulatory
  • Experience in managing international or regional regulatory submissions, normally a full international submission (new product application)
  • Experience in preparation and coordination of regulatory strategy plans
  • Extensive experience in the field of Biosimilars within a regulatory position.

To apply call me, Funmi Gbadamosi on 617 420 4128 for a confidential discussion. Please send your CV in MS WORD format to f.gbadamosi@nonstop-recruitment.com

If this does not sound like the right opportunity for you, feel free to contact me about other Pharmaceutical related positions I am working on.

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
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