Job Information
Bausch Health Senior Regulatory Affairs Specialist in Laval, Quebec
Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians.
Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country.
At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs.
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 as well 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 of responses to Health Canada letters (e.g. Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes) in timely manner.
Assist in the review and coordinate French translations of Product Monographs and product labelling.
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 (Labelling / 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.
Bausch Health is an EEO/AA employer M/F/D/V.