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Senior Regulatory Affairs Specialist

2 months ago

Laval, Quebec, Canada Bausch Health Full time
Career Opportunities: Senior Regulatory Affairs Specialist

Job Summary: We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Bausch Health. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.

Key Responsibilities:

  • Submission Preparation: Prepare and compile submissions to regulatory authorities in electronic Common Technical Document (eCTD) format, ensuring compliance with regulatory guidelines and requirements.
  • Regulatory Planning: Plan, manage, and coordinate the preparation, compilation, filing, and approval of regulatory submissions for presentation to regulatory authorities.
  • Data Assessment: Critically assess data and documents to identify gaps compared to regulatory requirements and elevate key areas of regulatory risk.
  • Regulatory Compliance: Maintain and ensure regulatory product compliance, interacting with internal and external stakeholders, including regulatory authorities.
  • Response Preparation: Prepare and review responses to regulatory authority letters (Notice of Non-Compliance, Notice of Deficiency, and Clarifaxes) in a timely manner.
  • Translation Coordination: Assist in the review and coordination of French translations of Product Monographs and product labeling.
  • Regulatory Negotiations: Assist in negotiations with regulatory authorities for prompt regulatory approvals of dossiers under review.
  • Document Collection: Liaise with groups internally and externally to collect necessary documents and information and provide regulatory support.
  • Regulatory Awareness: Maintain awareness of all regulatory guidelines (regulatory authority guidance documents, ICH, etc.).
  • Internal Review: Internal regulatory review of promotional products for branded pharmaceutical products.
  • Change Control: Review Change Controls and determine filing requirements (Labeling / Clinical).

Qualifications:

  • 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 solid experience in managing drug products, natural health products, and medical device licensing.
  • Skills: 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 for others. Computer Literacy – Microsoft Package including Word, Excel, and Outlook; Adobe Acrobat.