Senior Regulatory Executive

Senior Regulatory Executive

Executive Life Sciences Pharmaceuticals

Location London

Salary Up to £65/hour

Contract Contract

Reference TKregex

Date Posted

Consultant

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Senior Regulatory Executive

An excellent opportunity has arisen for an experienced Senior Regulatory Executive to join a global pharmaceutical company at their site based in London. Offered on an initial contract basis, this is a chance to work with a global leader and world-renowned organisation. The role will briefly comprise of the following:

  • Preparation of high quality, Chemistry, Manufacturing and Control (CMC) detailed regulatory documents using varied information sources. liaising closely with other personnel to ensure accuracy of such records.
  • Working to agreed deadlines and maintaining records to reflecting project status
  • Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving. Proactively pursuing process improvement and sharing of best practice

 

Required Skills

  • 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 partner sites worldwide
  • Be proficient in the use of IT packages such as Word and excel.
  • Demonstrate problem solving skills

 

Role Specific Requirements

  • Post Approval CMC experience preferential
  • CMC authoring experience essential, ideally including 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.

 

If this sounds like the opportunity for you, apply now with your CV, and feel free to contact Tom Kirkpatrick at CY Partners for more information and a confidential chat.

 

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Senior Regulatory Executive

Executive Life Sciences Pharmaceuticals

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