Senior Manager, Regulatory Affairs

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee and direct regulatory strategy and consulting projects for clients in the life sciences sector.

• Organize, prepare, review, and maintain regulatory submissions and related documentation, including CTAs, INDs, NDSs, NDAs and supplements, PLAs, DIN submissions, regulatory responses, amendments, and post-approval activities.

• Conduct due diligence reviews.

• Create product labeling.

• Assist in planning product launches and reviewing advertising/promotional materials.

• Act as the primary point of contact for designated clients and facilitate interactions with Regulatory Authorities.

• Lead or assist in agency meetings, prepare briefing materials, and offer strategic recommendations regarding emerging regulatory challenges.

• Collaborate with cross-functional teams, including development, quality, clinical, medical, commercial, and business units.

• Analyze changing regulatory requirements and convert regulatory intelligence into practical guidance.

• Oversee multiple projects, ensuring alignment with scope, timelines, budgets, and quality expectations.

• Identify and address regulatory risks, issues, and competing priorities.

• Ensure deliverables satisfy client requirements, standard operating procedures, and quality standards.

• Assist with proposals, presentations, new business discussions, and fostering client relationships.

• Share knowledge through training, mentoring, industry presentations, publications, and webinars.

• Manage decision-making processes and conflict resolution within assigned projects and the team.

• Engage in ongoing learning and provide training or coaching to colleagues.

• Undertake additional tasks as assigned.

⛳️ Requirements

• A Bachelor’s degree in a life-sciences field is required.

• 5–8 years of direct experience in regulatory affairs throughout the health product lifecycle.

• Experience in developing pre-market submissions and overseeing product lifecycle submissions/post-market modifications.

• Strong understanding of Canadian regulatory requirements and processes with Health Canada.

• Familiarity with applicable ICH requirements.

• Knowledge of FDA, EMA, and other international regulatory frameworks is advantageous.

• Experience managing or supporting interactions with Regulatory Authorities.

• Capability to lead multiple concurrent client projects while balancing timelines, scope, quality, and budget considerations.

• Strong strategic thinking, analytical judgment, and problem-solving skills.

• Excellent written, verbal, and presentation abilities.

• Ability to clearly articulate complex regulatory matters to diverse audiences.

• Capacity to build trusted relationships with clients and collaborate effectively in multidisciplinary teams.

• Strong business acumen and interest in proposals, client development, and practice growth.

• Bilingual in French and English, both written and spoken, is preferred.

• Regulatory Affairs Certification (RAC) and previous leadership or consulting experience are beneficial.

🏝️ Benefits

• Medical, dental, and vision care.

• Backup dependent care.

• Adoption assistance.

• Infertility coverage.

• Family building support.

• Behavioral health solutions.

• Paid parental leave.

• Paid caregiver leave.

• Training programs.

• Professional development resources.

• Mentorship programs.

• Employee resource groups.

• Volunteer activities.