Elevate Pharma - Specialists in Life Sciences Recruitment

Regulatory Affairs Manager – UK based

Reference:
EP170416
Sector:
Regulatory Affairs
Salary:
Salary negotiable
Town/City:
UK
Contract Type:
Permanent

An exciting opportunity within a leader global CRO for a Regulatory Affairs Manager to join their expanding Clinical Study Start-Up and Regulatory Affairs group. This is a full-time position based in the UK.

KEY RESPONSIBILITIES:

  • Effectively and rapidly coordinate & manage CTA submissions to regulatory authorities and ethics committees and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
  • Ensure high quality performance of deliverables are applied within the projects assigned and promptly identify and address any risk/potential risk by implementing preventive measures
  • Provide regulatory strategic advice to internal and external customers
  • Contribute towards the preparation and/or review of technical documentation (i.e. protocol, IMPDs and IBs) when required
  • Review and, if applicable, customise all relevant documentation (i.e. labels, patient information sheets, diary cards, insurance etc) to ensure high level of quality and compliance with ICH GCP & country specific requirements
  • Assist RA-BIDs and senior management in securing new business or repeated business by participating to BDMs, developing/ reviewing regulatory sections of proposals and regulatory costing and budgets
  • Provide coaching, advice and mentoring to regulatory members assigned to the projects (although the position will not have any direct line management responsibilities)

 SKILLS AND EXPERIENCE:

  • Bachelor's Degree in Chemistry or Life Sciences.
  • At least 5 years within pharmaceutical/CRO industry.
  • Ability to successfully manage global projects
  • Excellent ability to handle multiple tasks in a fast-paced environment
  • Expert knowledge of drug development
  • Expert knowledge of ICH GCP and the EU Clinical Trials Directive/Regulation and
  • National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)

In return for meeting the above criteria, the successful candidate will be rewarded with a very competitive basic salary.

Elevate Pharma is a specialist Life Sciences Recruiter and this vacancy is just one of a number of positions that we currently have available in this sector.