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Senior Regulatory Affairs Specialist

3 months ago

Laval Quebec HA, Laval region, Canada Bausch Health Full time
Career Opportunities: Senior Regulatory Affairs Specialist (11941)

Requisition ID 11941 - Posted - Canada Reg Affairs - R&D - CA - Laval - City (1)

Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest-growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.
Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices, and hospitals across the country.
At Bausch Health, we invest in our employees and believe in cultivating performance and finding new solutions to respond innovatively and effectively to current needs.

KEY RESPONSIBILITIES:
  • Prepare and compile submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, and medical device license applications) to Health Canada in eCTD format as per Health Canada’s Guidelines to obtain marketing authorization for new products and maintain conformity and life cycle of currently marketed products.
  • Plan, manage, and coordinate the preparation, compilation, filing, and approval of regulatory submissions for presentation to Health Canada.
  • Critically assess data and documents to identify gaps compared to regulatory requirements and elevate key areas of regulatory risk.
  • Maintain and ensure regulatory product compliance. Interact, communicate, and negotiate with internal and external stakeholders including Health Canada.
  • Prepare and review responses to Health Canada letters (Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes) in a timely manner.
  • Assist in the review and coordinate French translations of Product Monographs and product labeling.
  • Assist in negotiations with Health Canada for prompt regulatory approvals of dossiers under review.
  • Liaise with groups internally and externally to collect necessary documents and information and provide regulatory support.
  • Maintain awareness of all regulatory guidelines (Health Canada Guidance Documents, ICH, etc.).
  • Internal regulatory review of promotional products for branded pharmaceutical products.
  • Review Change Controls and determine filing requirements (Labeling / Clinical).
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.
  • Minimum 5 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent solid experience in managing drug products, natural health products, and medical device licensing.
  • Strong 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 for others.
  • Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat.

The masculine is used in this publication without prejudice for the sake of conciseness.
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.

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