Manager, Regulatory Affairs and Quality

  • 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