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Responsibilities
- Review, preparation, submission and follow-up of dossiers for new products and variations and renewal for existing products
- Manage the regulatory lifecycle for approved products
- Maintaining and managing GMP/GDP Quality System (covering pharmaceuticals, medical devices, cosmetics and nutritional products)
- Management and oversight of 3rd parties handling of pharmacovigilance and certain regulatory and quality activities (3PL)
- Acting as single point of contact for health authorities
- Full process management of the packaging (approvals and submissions)
- Close direct cooperation with global regulatory group
- Review and approval of medical marketing material
Qualifications
- BSc. or higher in a relevant discipline (Chemistry / Life Sciences / Pharmacy); diploma from a RA program would be preferred
- 5+ years Regulatory Affairs experience and extensive knowledge of GMP guidelines
- Extensive knowledge of Health Canada regulations for pharmaceuticals and medical devices
- Excellent communication skills (verbal and written). Experienced in negotiations and addressing deficiencies with regulatory authorities
- Strategic thinking and project planning/management