JOB TITLE: Sr Regulatory Affairs Specialist (CMC)

KEY RESPONSIBILITIES:

• Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory  submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, etc.) for presentation to Health Canada in eCTD format and as per Health Canada’s Guidelines to obtain marketing authorization for new or marketed drug products.
• Preparation and review of responses to Health Canada letters (e.g. SDN, NON, NOD, Clarifaxes) in a timely manner; assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
• Help to manage all regulatory CMC aspects of Bausch Health Canada Inc., Salix and Orapharma products in Canada throughout their lifecycle:

• Evaluation of change controls, determination of necessary requirements, preparation and compilation of L3 submissions to maintain the conformity and life cycle of currently marketed products; update of CPIDs and associated regulatory dossiers maintenance.
• Projects: critical assessment of data and documents to identify gaps compared to regulatory requirements; identify the required documentation and content of CMC sections in support of registrations in Canada.
• Formulate CMC regulatory strategy for marketed products in collaboration with RA Product Leads.

• Maintain and ensure regulatory product compliance. Interact, communicate and negotiate with internal and external stakeholders like Health Canada and CMOs.
• Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
• Mentor other members of the team on technical aspects.

• Support the Sr. Manager RA-CMC, and the GRA-CMC team (US/EU/Latam) as necessary.

QUALIFICATIONS:

• University Degree, B.Sc. or higher (Master’s degree or a PhD) in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset. Relevant Quality Assurance (analytical)/Compliance experience is also an asset.
• Minimum of 6 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective. Experience with Biologics is also an asset.
• Excellent working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
• Excellent organizational and communication skills (oral and written).
• Bilingual (English and French).
• Ability to prioritize projects, coordinate multiple projects simultaneously and work with tight deadlines.
• Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility & flexibility; team player and respect of others.
• Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat, Veeva, Docubridge, Trackwise.