Regulatory Senior Executive - 84809

Regulatory Senior Executive - 84809
  • Competitive
  • West London, London, England, UK West London London UK TW8 9GS
Job Ref: J2157227
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 28 September 2020
We are looking for candidates who understand & auhtor tecnhical content of Module 3 dossiers and worked directly with manufacturing sites

Our client a Global Pharmaceutical Company have opened a new vacancy within there Regulatory team and are looking to recruit x2 Senior Regulatory Executive's on 12 month contracts based in Brentford after COVID.

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
  • Good written and oral communication and networking skills
  • Demonstrate ability to focus and work with attention to detail
  • Demonstrate ability to retain critical information
  • Be aware of the contents of a marketing authorization application
  • Demonstrate team working and effective time management skills
  • Be a dynamic and highly motivated individual
  • Establish strong relationships and liaise effectively with company sites worldwide
  • Be proficient in the use of IT packages such as Word and excel.
  • Demonstrate problem solving skills

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

28/10/2020 11:06:27
Contact Consultant:
Natasha Rollason

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