Regulatory Affairs Specialist
4 weeks 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 variety of pharmaceutical and health products distributed in pharmacies, healthcare practices, and hospitals across the country.
As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our pharmaceutical products with Health Canada regulations. Your responsibilities will include planning, managing, and coordinating the preparation, compilation, filing, and approval of high-quality regulatory submissions for presentation to Health Canada.
Key Responsibilities:
- Prepare and review responses to Health Canada letters in a timely manner.
- Evaluate change controls, determine necessary requirements, and prepare and compile L3 submissions to maintain conformity and life cycle of currently marketed products.
- Critically assess data and documents to identify gaps compared to regulatory requirements.
- Maintain and ensure regulatory product compliance, interacting and communicating with internal and external stakeholders like Health Canada.
- Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc.).
Qualifications:
- University Degree, B.Sc. or higher, in Health Sciences, with a Master's degree or PhD in Drug Development and/or RAC certification.
- 3-4 years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective.
- Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
- Excellent organizational and communication skills, with the ability to prioritize projects, coordinate multiple projects simultaneously, and work with tight deadlines.
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