Job Description

Your Role:

The Regulatory Affairs Project Leader, reporting to the Director of Regulatory Affairs, is responsible for the planning, submission and management of regulatory activities for lifecycle products and strategic products. This involves the assisted leadership in regulatory strategy development and implementation / management of regulatory activities to achieve optimal submission outcomes.

Specific Responsibilities:

• Overall responsibility for the independent efficient timely preparation of submission dossiers
• Assisted leadership in the evaluation and development of key elements regarding regulatory strategies (risks and opportunities) for new products and strategic growth products.
• Manage the Health Canada submission review process to the earliest approval date with optimal labeling.
• Maintain registration compliance for approved products to support the ongoing marketing in Canada.
• Provide strategic advice to local partners on regulatory issues and strategies in cross-functional teams and initiatives. Build and maintain positive and productive relationships with internal interfaces
• Represent the Regulatory Affairs function in global regulatory strategic teams
• Responsible for the strategic creation, review, approval and maintenance of product labeling locally.
• Support clinical trial development activities for development products and pipeline development strategic evaluations
• Build and maintain positive and productive relationships with external contacts (e.g. Health Canada) and internal interfaces.
• Preparation or support of submissions including CTAs, NDS, S/NDS, NC, Level III and medical device licenses) Extensive contribution to the development of regulatory dossier documentation including autonomous critical analysis of data
• Fully responsible for the creation, review, approval and maintenance of product packaging artwork and Product Monographs to ensure compliance with the Canadian Food and Drugs Act and Regulations and internal standards.
• Significantly contribute to the management of Pre-submission Meeting activities with Health Canada.
• Review and approve promotional materials
• Maintain document management for all Regulatory files and correspondence within regulatory systems (e.g. Veeva)
• Contribute to the authoring and improvement of regulatory working instructions/flow processes/procedures including implementation of new regulatory requirements and policies
• Review and execute change control procedures that are performed at the local level
• Remain up to date on applicable laws, regulations, policies and guidelines including participation in the review / commenting of new requirements / guidelines consultations
• Alert Director to issues and potential problems, delays and/or deficiencies – making recommendations as appropriate.
• Position is on site with 5% travel 5%

Who You Are

Minimum Qualifications:

• 4+ years of work experience in Regulatory Affairs with biotechnology or pharmaceutical products
• Bachelor’s degree

Preferred Qualifications:

• Advanced degree and post-graduate regulatory affairs certification are assets

• Demonstrated knowledge of the Canadian Food and Drugs Act and Regulations and relevant Health Canada policies and guidance documents.
• Solid understanding of product development, including pharmacology, toxicology, pharmacokinetics and clinical studies.
• Strong analytical skills with the ability to assess scientific data.
• Excellent communication skills, including written, verbal, and negotiation.
• Strong organizational and project management skills including the ability to manage multiple projects and priorities effectively.
• Strong organizational and project management skills including the ability to manage multiple projects and priorities effectively.
• Demonstrated interpersonal skills with respect to relationship building and teamwork.
• Demonstrated attention to detail
• Strong business acumen