Job Reference: WS1
Principle Consultant (CMC) UK
- Bishop's Stortford, Hertfordshire
- £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.
- 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.
- 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:
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