Global Regulatory Affairs Director

Employment Permanent Date display: 04/04/2018 #Ref.:2309

Activity area : Pharmaceutical and medical

Post category : Executive search, Scientific and technical positions

Province : Ontario

Region : Greater Toronto Area, Toronto

Recruiter : Anne Loiselle

Contact us :

Job description :

Our client, a large private pharmaceutical company is looking for a Director of Global Regulatory Affairs.   In this new exciting role, you would be responsible for the filing strategies for its novel compounds (INDs) with the FDA, EMA, Japanese authorities and other local regulatory agencies with the aim of gaining marketing approvals worldwide.   You would be the primary point of contact with the agencies with respect to product submissions, approval and other relevant processes.

You would lead a team of 6-10 regulatory professionals.   Be responsible for the budgets, staffing issues and development needs.

Skills and qualifications :

  • Advanced degree (e.g. MSc, PhD) or managerial & technical professional qualifications.

  • 7-10 years in management of a regulatory affairs team.

  • Solid, robust knowledge of the US regulatory landscape, practice and culture gained by first-hand and broad experience with FDA interaction (a must).

  • Sound knowledge of EU and Canadian regulatory landscape, including interaction with agencies (highly desirable).

  • Experience filing INDs with the Japanese regulatory agency (nice to have).

  • Strong and confident regulatory affairs advocate – able to discuss and argue from evidence about regulatory strategies and tactics.

  • Located or willing to relocate to Toronto.