Regulatory Senior Executive 84201

Regulatory Senior Executive 84201
  • Competitive
  • Contract
  • Brentford, London, England, UK Brentford London UK TW8 9GS
Job Ref: J36801
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 20 July 2020
SRG are looking for x4 Senior Regulatory Executives on 12 month contracts.

Our client a Global Pharmaceutical Company have opened a new vacancy within there Regulatory team and are looking to recruit x4 Senior Regulatory Executive's on 12 month contracts.

Key Responsibilities/Requirements:

  • Post Approval CMC experience
  • CMC authoring experience essential (previous co-ordination role is not sufficient). This should include authoring of module 3 and authoring of CMC variations
  • Experience responding to manufacturing site change controls and providing regulatory advice and strategies
  • Detailed proven CMC knowledge and experience for EU and EMAP region
  • Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
  • Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions
  • Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
  • Ability to efficiently interact with customers and senior stakeholders as required
  • Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
  • Good communication skills and flexible approach - " can do attitude"
  • May contribute to process improvement and/or regulatory intelligence projects

Skills/Experience Required:

  • CMC experience
  • The right candidate must be able to understant technical content of module 3 dossiers, have worked directly with manufacturing sites and understand CMC specific legislation/guidance globally and can author module 3 content.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

19/08/2020 15:00:44
Contact Consultant:
Natasha Rollason

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