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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
**Job Summary**
Bausch Health Canada is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for planning, managing, and coordinating the preparation, compilation, filing, and approval of high-quality regulatory submissions for presentation to Health Canada.
**Key Responsibilities**
* Plan, manage, and coordinate the preparation, compilation, filing, and approval of high-quality regulatory submissions (NDS, SNDS, ANDS, SANDS, NC, DINA, PDC, etc.) for presentation to Health Canada in eCTD format and as per Health Canada's Guidelines to obtain marketing authorization for new or marketed drug products.
* Preparation and review of responses to Health Canada letters (e.g. Notice of Non-Compliance, Notice of Deficiency, Clarifaxes) in timely manner; assist in negotiations with Health Canada to ensure prompt regulatory approvals of dossiers under review and in preparation.
* Evaluation of change controls, determination of necessary requirements, preparation and compilation of L3 submissions to maintain the conformity and life cycle of currently marketed products; update of CPIDs and associated regulatory dossiers maintenance.
* Critical assessment of data and documents to identify gaps compared to regulatory requirements.
* Maintain and ensure regulatory product compliance. Interact, communicate and negotiate with internal and external stakeholders like Health Canada.
* Maintain current awareness of all regulatory guidelines (Health Canada, ICH, etc).
* Support the Sr. Manager RA-CMC as necessary.
**Qualifications**
* University Degree, B.Sc. or higher (Master degree or a PhD) in Health Sciences. A DESS in Drug Development and/or a RAC certification is an asset. Relevant Quality Assurance/Compliance experience is also an asset.
* Years of relevant CMC experience in Canadian Pharmaceutical Regulatory Affairs, with experience/expertise in managing drug products and lifecycle from a CMC perspective. Experience with Biologics is also an asset.
* Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
* 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, Veeva, Docubridge, Trackwise.
**What We Offer**
Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
