Senior Regulatory Affairs Specialist

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, and medical aesthetic devices. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action-oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

KEY RESPONSIBILITIES:

• Prepare and compile type of 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 (e.g. prescription drugs, OTCs and medical devices) and to maintain the conformity and life cycle of currently marketed products (e.g. prescription drugs, OTCs and medical devices).
• Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions for presentation to Health Canada.
• Critical assessment of data and documents to identify gaps compared to regulatory requirements as well as identify and elevate key areas of regulatory risk.
• Maintain and ensure regulatory product compliance. Interact, communicate, and negotiate with internal and external stakeholders like Health Canada.
• Prepare and review responses to Health Canada letters (e.g. 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 to ensure prompt regulatory approvals of dossiers under review and in preparation.
• Liaise with groups, internally and externally, to collect necessary documents and information and provide regulatory support.
• Maintain current awareness of all regulatory guidelines (Health Canada Guidance Documents, ICH, etc.).
• Internal regulatory review of promotional products for branded pharmaceutical products.
• Review of Change Controls and determination of 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 (2-3 years), solid experience/expertise in managing drug products (Rx, Ethical, DIN-OTC), natural health products (NPN) and medical device licensing (if applicable).
• Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products (drug products and medical devices).
• 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 of 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.