Senior Manager in Regulatory Affairs

  • Salary: Competitive
  • REF Number: 00033579
  • Consultant: Oliver Care
  • Contact: 01438 743047
  • Date Published: 18.08.2015
  • Closed Date: 17.02.2016
  • Sector:
  • Location: Berkshire,
  • Discipline:

Oliver Care at CK Clinical is recruiting for a Senior Manager in Regulatory Affairs 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 provide advice and counsel on labeling requirements during discussions and concepts during early stage product development.
  • Leading cross-functional teams in the development and lifetime maintenance of the SmPC and other labeling for assigned therapeutic areas.
  • Ensuring alignment of overall key labeling statements and key messages across labeling documents.

Further responsibilities will include:

  • Defining and implementing labeling strategy for development compounds and marketed products in the assigned regional area.
  • Leading or supporting project work related to labelling improvements or compliance such as house-style, post code update or label review.
  • Accountability as required for escalating issues to upper management, evaluating risks and developing mitigation plans for labeling in cooperation with regulatory senior management.

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.
  • Significant regulatory, R&D or related area, with experience in regulatory affairs labeling or equivalent experience within the pharmaceutical industry.
  • 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 743047 or email Alternatively please click on the link below.

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 CL33579 in all correspondence.

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