Senior Regulatory Affairs Manager

  • Salary: Competitive
  • REF Number: 00032953
  • Consultant: Oliver Care
  • Contact: 01438 743 047
  • Date Published: 26.06.2015
  • Closed Date: 17.02.2016
  • Sector:
  • Location: Oxford,
  • Discipline:

Oliver Care at CK Clinical is recruiting for a Senior Regulatory Affairs Manager to join a company in the Biopharmaceutical industry, based in Oxfordshire, on a full time, permanent basis.

The main purpose of the role will be:

  • To prepare, compile, review and submit documentation to EU, US and Rest of World MAA / (A)NDAs, CTAs / INDs, and agency interactions.
  • To prepare, compile and review variation, amendment and supplement submissions for clinical trials and marketing authorisations.- To contribute to continuous improvement and compliance, including Standard Operating Procedures (SOPs) and regulatory status tracking systems.

Further responsibilities will include:

  • Representing the company in external Regulatory and Development meetings.
  • Regulatory representation in multidisciplinary project matrices for development projects.
  • Maintaining all documents on approved and newly filed products.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

  • Bachelor of Science in a scientific or healthcare discipline
  • Significant experience in Regulatory Affairs, ideally in the generic pharmaceutical industry

For more information or to apply for this position, please contact Oliver Care on 01438 743 047 or email ocare@ckclinical.co.uk.

CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL32953 in all correspondence.

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