Senior Director, Regulatory Affairs
City : See posting
Category : See posting
Industry : Pharmaceutical/Healthcare
Employer : Teva Canada
Who are we?
The Senior Director, Regulatory Affairs is responsible to oversee and manage Specialty RA and BioSimilars RA activities with Health Canada. The individual will liaise with Teva peers in the global RA organization, in global R&D, Operations and the Canadian Commercial organization. The individual will develop regulatory strategies for key innovative and biosimilars assets, and will coordinate engagement with Health Canada throughout the development and maintenance phases. The individual will be responsible to lead a small team of experienced regulatory professionals.
Essential Duties & Responsibilities
- Lead Teva’s Global Specialty Regulatory Affairs department in engaging with Health Canada on innovative pharmaceuticals and biosimilars products.
- Develop regulatory strategies for approved assets and for assets in various stages of development. Communicate strategies effectively within R&D and to Commercial organization. Represent RA dept in cross-functional forums and successfully negotiate to ensure regulatory objectives are met.
- Review incoming/outgoing Health Canada correspondence (NDSs, amendments, annual reports, supplements) and determine appropriate course of action.
- Support review of labeling, advertising/promotional materials for innovative and biosimilars assets.
- Supervise and train direct reports, conduct performance evaluations, dispute resolution, etc. Ensure adherence to dept procedures and compliance with company standards.
- Participate in industry association activities, conduct due diligence activities, interact with development/business partners, manage department budget, develop and monitor appropriate department metrics, and perform other duties, as assigned, or as business needs require.
- Minimum Bachelors in Science degree in scientific or healthcare discipline, equivalent combination of education and related experience. Education Preferred: R.PH., Pharm.D, M.S., Ph.D., or equivalent combination and related experience.
- 10+ years in pharmaceutical regulatory affairs with knowledge of clinical drug development, labeling, and CMC. Innovative drug development experience is a must.
- 3+ years in a supervisory position. Experience in innovative drug development, with 3+ years experience with biologics. Biosimilar knowledge a plus.
- Fluently bilingual in French and English, written and spoken.
- R.Ph., and/or RAC certification is beneficial, but not mandatory. NDS submissions and approval requirements, working knowledge of chemistry, manufacturing and controls as needed for NDS submissions.
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