Job Description

Who are we?

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!



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.

Qualifications

• 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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Teva's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.