Regulatory Affairs Director

Recruiter
Regulatory Professionals
Location
Cambridgeshire
Posted
10 Oct 2018
Closes
15 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Regulatory Affairs Director - Biosimilars12 month contractCambridge based - 2 days home working flexibility consideredMy client an international leader within the pharmaceutical industry seeks a Regulatory Affairs Director to lead the global submission and approval of oncology biosimilar. Acting as the point of contact for biosimilar related regulatory queries you will lead the submission and approval of 1-2 oncology biosimilars in EU/US and ROW by 2020.Job Requirements include;- Responsible for planning, developing and managing the biosimilar regulatory dossier for global submission- Responsible for regulatory interactions in partnership with appropriate technical experts- Act as the leader for post approval submission activities including post maintenance, supply and compliance activities- Monitor changes in the regulatory environment, both general and specific to the therapeutic areaCandidate Requirements includes;- Life sciences degree or equivalent - Strong strategic leadership skills- 5 years experience of regulatory drug development including product approval/launch- Candidates must have global submission experience- Understanding of regional (EU or US) and/or global regulatory science & drug development processes and strategies- Previous experience within oncology would be advantageousIf this position is of interest to yourself, please submit your CV to sophie@regulatoryprofessionals.com or call via 0118 952 2797.

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