Regulatory CMC Associate Director

CK Group are recruiting for a Regulatory CMC Associate Director join a company in the Pharmaceutical industry at their site based in Macclesfield or in Cambridge on a contract basis for 12 months. This role offers hybrid work with 1-2 days per week in the office.

Salary:

• 70-£90ph LTD outside IR35

Regulatory CMC Associate Director Role:

• Support application of progressive thinking and regulatory CMC expertise to TA and non-TA projects.
• Will typically have responsibility for development projects for new biologics, other modalities and post approval product support.
• Project manage to ensure project activities and documentation are delivered to a high standard, agreed time scales and meet AZ business requirements, compliance requirements regarding manufacturing and development and regulatory authority expectations worldwide.
• Supports the strategy for fit for purpose content of CMC submissions and review and approve regulatory CMC documents. Such submissions areclinical trial applications (IND, CTA, etc), marketing authorisation applications (NDA, MAA, JNDA etc), line extensions, or post approval activities.
• Working with the Reg CMC team to provide technical functions clear, concise guidance on currentCMC regulatory requirements, as well as creative thinking for alternative Reg. acceptable strategies, to support business tactical or strategic planning.

• Participate and/or lead various multi-disciplinary teams or taskforces related to CMC/productYour Background:

• Experienced graduate or in a scientific discipline, typically chemistry, pharmacy or a biological science.

• Knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture
• Typically, 5+ years’ experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufactur.
• Awareness of regulatory requirements and submissions pathways.
• Significant project or line management experience in a relevant environment.

Company:

Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

Location:

This Analytical Scientist role will be based at our clients site in Macclesfield, Cheshire.

Apply:

For more information, please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52255. Entitlement to work in the UK is essential for this role.nce 52288.

CLINGENutcomes, retrospective and prospective data analyses, registry, epidemiology or health services research

• Expert insight and knowledge in Health economics and model development
• Skilled in translating complex economic concepts into simple language.
• Good understanding of current UK health care system and market access issues
• Demonstrated experience of project management
• Strong numeric skills
• Scientific/medical knowledge
• A commercial mindset

Apply: Entitlement to workin the UK is essential. For more information or to apply for this Health Economics Manager position, please contact Steve Lord on 01246 457733 or email slord@ckgroup.co.uk. Please quote reference 52358 in all correspondence.