Regulatory Affairs Director
CK Group are recruiting for a Regulatory Affairs Director to join a company in the Pharmaceutical industry on a contract basis for 12 months. This position is remote for UK-based contractors only.
Rate: Up to £750 per day LTD (Experience dependent)
Regulatory Affairs Director Role:
- Lead submission and approval of oncology biosimilars in EU/US and ROW
- Lead health authority interactions along with technical experts to facilitate approval
- Lead and responsible for planning, developing and managing the biosimilar regulatory dossier for global submission.
- Lead and responsible for post approval submission activities including product maintenance, supply and compliance activities
- At least a Bachelor's degree in a scientific or related field
- Extensive regulatory affairs experience in the pharmaceutical industry including product approval/launch.
- Oncology and biologics/antibody experience is essential
- Specific US regulatory approvals is essential
- Strong project management experience, capable of managing a team across the globe
Company: Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.
Apply: For more information, please contact Andy or Lucy on 01438 870011 or email firstname.lastname@example.org. Pleasequote reference 49124.