Regulatory Affairs Project Manager

  • Salary: Competitive
  • REF Number: 00033556
  • Consultant: Oliver Care
  • Contact: 01438 842976
  • Date Published: 14.08.2015
  • Closed Date: 17.02.2016
  • Sector:
  • Location: Berkshire,
  • Discipline:

Oliver Care at CK Clinical is recruiting for a Regulatory Affairs Project Manager to join a company in the biopharmaceutical industry at their site based in Berkshire on a permanent basis.

The main purpose of the role will be to

  • Support the generation of the global regulatory strategy including identifying risks and appropriate mitigations and opportunities and develop regulatory strategies in collaboration with global regulatory teams, regional brand teams and affiliates.
  • Implement the successful planning and execution of regulatory activities against agreed strategies to support products and projects in the EU, Switzerland, Turkey and Israel.
  • Support a wide range of regulatory activities/systems in Western Europe including MAAs, scientific advice, pediatric plans and centralised post-authorisation activities.

Further responsibilities will include:

  • Communicating regulatory strategy and scientific data effectively including gap analysis and mitigation strategies.
  • Creating supportive partnerships with Regulatory Affairs staff in affiliate companies.
  • Working in partnership with internal and external stakeholders

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

  • Educated to degree level or above in Life Sciences or a related field with a sound knowledge of the EU regulatory environment, considerable previous experience in Regulatory Affairs, the ability to assess impacts on regulatory strategy, anticipate risks and develop potential solutions.
  • Proven experience in filling submissions including CTD, MAA, labelling changes, DSUR, PSUR RMP and interacting with Regulatory Authorities
  • Excellent project management, organisation, communication and interpersonal skills.

This is an excellent opportunity to join a leading biopharmaceutical company with a diverse product portfolio with the opportunity to expand on your experience in R&D related Regulatory Affairs

Benefits include an attractive remuneration package.

For more information or to apply for this position, please contact Oliver Care on 01438 842976 or email Alternatively, please click on the link below to apply online now.

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 CL33556 in all correspondence.

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