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Job Details

Regulatory Affairs Manager - Pharma, UK

Company: Barrington James Clinical
Reference: CRBG - RAMPH
Closing Date: 09 Aug 18
Type: Permanent
Salary (£): Competitive

Job Summary:

Regulatory activities associated with worldwide development including development of regulatory strategy, due diligence, gaining regulatory approvals for clinical trial and marketing applications and maintenance of these authorisations where appropriate.


Key Accountabilities:

  • Management of compliance with relevant regulatory legislation and guidelines.
  • Defining project and product regulatory strategy of the Development Group in line with commercial and company strategy, consulting with appropriate departments where necessary.
  • Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice.
  • Management of the regulatory activities associated with project team plans.
  • Management of the preparation, attendance and follow-up of meetings with Regulatory Agencies (e.g. requests for scientific advice) including the generation of briefing documents and minutes.
  • Management of the production of paper and electronic regulatory submissions including applications for clinical trials and marketing authorisations.
  • Ensuring maintenance of clinical trial authorisations including follow-up of commitments as a condition of approval.
  • Provide support for regulatory activities associated with due diligence for in- and out-licensing activities.
  • Management of the provision of information requested by regulatory authorities.
  • Ensuring effective communications between the Development Group and regulatory authorities, licensing partners and country contacts.
  • Ensuring that new safety information received is acted upon, as appropriate, in a timely manner.
  • Personal development and training.
  • Involvement in the selection of junior regulatory staff, development and training

Position Requirements

  • Life science qualification with a minimum of extensive experience in regulatory affairs in the pharmaceutical industry.
  • Expert regulatory knowledge
  • Capable of managing staff


  • Competitive salary
  • Pension scheme
  • Private medical insurance
  • Other voluntary benefits include: Childcare Vouchers, Bike to Work

Apply for this job: Regulatory Affairs Manager - Pharma, UK

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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