Regulatory Affairs Specialist
1 month 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 that are distributed across the country.
Key Responsibilities:- Prepare and compile regulatory submissions to Health Canada in eCTD format, ensuring compliance with guidelines and regulations.
- Plan, manage, and coordinate the preparation, compilation, and approval of high-quality regulatory submissions.
- Critically assess data and documents to identify gaps and regulatory risks, and elevate key areas for attention.
- Maintain and ensure regulatory product compliance, interacting with internal and external stakeholders, including Health Canada.
- Prepare and review responses to Health Canada letters, ensuring timely and accurate communication.
- Assist in the review and coordination of French translations of Product Monographs and product labeling.
- Negotiate with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
- Liaise with internal and external groups to collect necessary documents and information, providing regulatory support.
- Maintain current awareness of all regulatory guidelines, including Health Canada Guidance Documents and ICH.
- Internal regulatory review of promotional products for branded pharmaceuticals.
- Review of Change Controls and determination of filing requirements.
- University Degree, B.Sc. or higher, in Health Sciences, with a DESS in Drug Development and/or RAC certification an asset.
- Minimum 5 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent 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, with bilingualism (English and French) a requirement.
- Ability to prioritize projects, coordinate multiple projects simultaneously, and work with tight deadlines.
- Entrepreneurship, focus on customer needs, good business acumen, and a sense of urgency, with agility and flexibility.
- Computer literacy, including Microsoft Package and Adobe Acrobat.
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