Regulatory Affairs Coordinator
6 days ago
Bausch Health Canada is a leading pharmaceutical company dedicated to delivering high-quality health and wellness products to Canadians.
Our team is responsible for manufacturing and marketing a wide range of pharmaceutical and health products that are distributed across the country.
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with Canadian regulatory guidelines and regulations.
Key Responsibilities:- Regulatory Submission Preparation: Prepare and compile regulatory submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, and medical device license applications) to Health Canada in eCTD format where applicable and as per Health Canada's Guidelines to obtain marketing authorization for new products and to maintain the conformity and life cycle of currently marketed products.
- Regulatory Planning and Coordination: Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions for presentation to Health Canada.
- Critical Assessment and Risk Management: Critical assessment of data and documents to identify gaps compared to regulatory requirements as well as identify and elevate key areas of regulatory risk.
- Regulatory Compliance and Communication: Maintain and ensure regulatory product compliance. Interact, communicate, and negotiate with internal and external stakeholders like Health Canada.
- Response to Health Canada Letters: Prepare and review responses to Health Canada letters (e.g. Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes) in a timely manner.
- Translation and Review: Assist in the review and coordinate French translations of Product Monographs and product labelling.
- Negotiations and Liaison: Assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
- Regulatory Support: Liaise with groups, internally and externally, to collect necessary documents and information and provide regulatory support.
- Regulatory Awareness: Maintain current awareness of all regulatory guidelines (Health Canada Guidance Documents, ICH, etc.…).
- Internal Regulatory Review: Internal regulatory review of promotional products for branded pharmaceutical products.
- Change Control and Filing: Review of Change Controls and determination of filing requirements (Labelling / Clinical).
- Education: 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.
- Experience: Minimum 5 years of relevant experience in Canadian Pharmaceutical Regulatory Affairs, with recent (2-3 years), solid experience/expertise in managing drug products (Rx, Ethical, DIN-OTC), natural health products (NPN) and medical device licensing (if applicable).
- Skills and Knowledge: Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products (drug products and medical devices).
- Language: Bilingual (English and French).
- Soft Skills: Excellent organizational and communication skills (oral and written). 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: Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat.
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