Senior Manager, Regulatory Affairs

CanadaRemoteFull-timesenior

Legal & ComplianceRegulatory

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Key Responsibilities

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Legal & ComplianceRegulatory

This is an exciting opportunity for an experienced regulatory affairs professional to provide strategic guidance and lead complex regulatory consulting projects across the health product lifecycle. You will support life sciences clients in navigating regulatory requirements for pharmaceuticals, biologics, medical devices, natural health products, and cosmetics. Combining deep technical expertise with strong client leadership, you will develop regulatory strategies that help products progress from clinical development through approval and commercialization. You will work closely with clients, Health Canada, the U.S. FDA, and multidisciplinary teams to address regulatory challenges and deliver practical solutions. The role offers broad exposure to regulatory submissions, product launches, agency interactions, and business development. You will also contribute to the development of colleagues and the continuous improvement of consulting services in a collaborative, client-focused environment.

Lead regulatory strategy and consulting engagements for life sciences clients across the health product lifecycle.
Direct the planning, preparation, review, submission, and maintenance of regulatory documentation, including Clinical Trial Applications (CTAs), Investigational New Drug applications (INDs), New Drug Submissions (NDSs), New Drug Applications (NDAs), supplements, Product Licence Applications (PLAs), and Drug Identification Number (DIN) submissions.
Oversee regulatory responses, amendments, post-approval activities, and other product lifecycle submissions.
Conduct regulatory due diligence reviews and develop product labeling in accordance with applicable requirements.
Support product launch planning and review advertising and promotional materials for regulatory compliance.
Act as a primary point of contact for assigned clients, building trusted relationships and supporting effective interactions with Regulatory Authorities.
Lead or contribute to agency meetings, prepare briefing materials, and provide strategic recommendations on regulatory matters.
Collaborate with development, quality, clinical, medical, commercial, and business teams to align regulatory strategies with broader product and organizational objectives.
Monitor evolving regulatory requirements and translate regulatory intelligence into clear, actionable guidance for clients and internal stakeholders.
Manage multiple concurrent projects, ensuring delivery within agreed scope, timelines, budgets, and quality standards.
Identify, assess, and resolve regulatory risks, issues, and competing priorities using sound judgement and a practical, solutions-oriented approach.
Ensure all deliverables comply with client requirements, standard operating procedures, and quality expectations, while identifying opportunities for process improvement.
Support practice growth through proposals, presentations, new-business discussions, and client relationship development.
Share regulatory expertise through internal training, coaching, mentoring, industry presentations, publications, and webinars.
Lead decision-making and conflict resolution on regulatory matters within assigned projects and teams.
Maintain professional expertise through continuous learning and contribute to the development of colleagues.

Requirements

~2 min read

Bachelor's degree in a life sciences discipline; an advanced degree in a relevant scientific or regulatory field is preferred.
5–8 years of direct Regulatory Affairs experience across the health product lifecycle.
Experience developing pre-market regulatory submissions and managing product lifecycle submissions and post-market changes.
Clinical research or regulatory consulting experience is preferred.
Strong working knowledge of Canadian regulatory requirements and Health Canada processes, with familiarity with relevant International Council for Harmonisation (ICH) guidelines.
Familiarity with U.S. FDA, European Medicines Agency (EMA), and other international regulatory environments is an asset.
Experience managing or supporting interactions with Regulatory Authorities.
Demonstrated ability to lead several concurrent client projects while balancing timelines, scope, budgets, and quality expectations.
Strong strategic thinking, analytical judgement, problem-solving, and decision-making skills.
Excellent written, verbal, and presentation skills, including the ability to communicate complex regulatory topics clearly to diverse audiences.
Proven ability to build trusted client relationships and collaborate effectively with multidisciplinary teams.
Strong business acumen and an interest in contributing to proposals, client development, and consulting practice growth.
Ability to take ownership of client relationships and lead senior-level discussions with confidence.
Adaptability and sound judgement when addressing ambiguous, time-sensitive, or complex regulatory challenges.
Commitment to continuous learning and sharing knowledge with colleagues and clients.

Additional assets:

French-English bilingualism, both written and spoken.
Regulatory Affairs Certification (RAC).
Previous people-management, team-leadership, or regulatory consulting experience.