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Job Details

Regulatory Affairs Manager - Pharma, UK

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

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.

Requirements:

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

Benefits:

  • 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
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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