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Regulatory Affairs Specialist
2 months ago
Bausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.
Key Responsibilities:- Prepare and compile regulatory submissions to Health Canada in eCTD format 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 in a timely manner.
- Assist in the review and coordination of 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.
- Internal regulatory review of promotional products for branded pharmaceutical products.
- Review Change Controls and determine filing requirements.
- University Degree, B.Sc. or higher 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.
- 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.
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
