Regulatory Affairs Director

  • Salary: Competitive
  • REF Number: 00034976
  • Consultant: Oliver Care
  • Contact: 01438 842 976
  • Date Published: 29.01.2016
  • Closed Date: 12.05.2016
  • Sector: Oncology
  • Location:
  • Discipline: Regulatory Affairs

Oliver Care at CK Clinical is recruiting for a Regulatory Affairs Director to join a company in the pharmaceutical industry at their site based in Cambridge for maternity cover on a contract basis.

The main purpose of the role will be:

  • To be accountable for the development and implementation of the regulatory strategy for a product or a group of products and for ensuring that the strategy is designed to deliver the needs of the business.
  • To possess strategic leadership skills with good understanding of regional and global regulatory science and overall drug and biologic development processes and strategies.
  • Leading and developing a regional and global regulatory strategy that is reflective of applicable domestic and international requirements.
  • Leading the planning and construction of the global dossier.

Further responsibilities will include:

  • Conducting regulatory risk planning and mitigation.
  • Serving as the single point of contact and Global Regulatory Affairs representative for regional and global teams.
  • To be accountable for product maintenance, supply and compliance activities associated with marketed brands.

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.
  • Should have experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA etc.)
  • Should have strong experience in regulatory drug development including product approval/launch.
  • Should have expert knowledge of regulatory affairs within oncology.

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

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 CL34976 in all correspondence.

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