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Job Reference: WS1

Principle Consultant (CMC) UK

  • Bishop's StortfordHertfordshire
  • £75000 - £100000 per annum
  • Permanent / Full Time

Seven Life Sciences are looking for a Principal Consultant, Quality/Chemistry Manufacture and Control to join our global team in a full-time position based in Bishops Stortford.

The role Pays up to £100k per annum based on experience. 

This is a hybrid role with 1-2 days on site in Bishops Stortford.

Job Role:

  • Provide Strategic, technical and regulatory advice/services to clients in the area for chemistry, manufacture and control for the devlopment of human medicinal products.
  • Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Chemistry Manufacture and Control perspective for complex products within the changing regulatory environment. 
  • Contribute to technical authorship of Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, Clinical Trial Applications, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications
  • Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Chemistry Manufacture and Control perspective for complex products within the changing regulatory environment
  • Represent clients in regulatory agency interactions and providing regulatory solutions to agency objections.

Requirements:

  • 15 years experience of drug development, with at least 5 years in the area of biotechnology.
  • Experienced at providing technical post marketing solutions for authorised medicinal products, with a strong emphasis on the concepts of biotechnological comparability challenges.
  • Experience in negotiation with multinational regulatory authorities including, as a minimum European and US authorities. 

Working with Seven Life Sciences:

We have been helping professionals find exciting new roles for almost a decade, so we know exactly where to look when it comes to sourcing the best opportunities. We operate across the UK, and, with over 300 five-star reviews, multiple awards and amazing relationships with the biggest employers in UK Life Science, we give you the best chance of landing your next role.

We have a reputation for recruiting at lightning speed, however, we can only respond to candidates who meet the exact requirements of the position. If you have any queries about a role or application, please visit our website where our amazing candidate support team will be more than happy to help

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