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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory strategy and compliance within the life sciences sector, with a strong focus on managing submissions, client interactions, and cross-functional collaboration. Proficient in navigating Canadian regulatory requirements and leading multiple projects while ensuring quality and adherence to timelines.
Highest-signal resume keywords
Regulatory Affairs ExperienceCanadian Regulatory RequirementsPre-Market SubmissionsRegulatory Affairs Certification (RAC)Bilingualism in French and English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory SubmissionsProduct Lifecycle ManagementDue Diligence ReviewsProduct Labeling DevelopmentRegulatory Risk ManagementStrategic RecommendationsRegulatory Intelligence InterpretationProject ManagementClient Relationship DevelopmentHealth Canada Processes
Soft Skills
Strategic ThinkingAnalytical JudgementProblem-SolvingCommunication SkillsCollaboration
Certifications & Qualifications
Regulatory Affairs Certification (RAC)
Industry Keywords
Life SciencesHealth Product LifecycleFDAEMAICH RequirementsRegulatory AuthoritiesClient DevelopmentMultidisciplinary TeamsContinuous LearningTraining and Mentoring
About the role
Key responsibilities & impact- Lead and manage regulatory strategy and consulting engagements for life sciences clients
- Plan, prepare, review and maintain regulatory submissions and associated documentation, including CTAs, INDs, NDSs, NDAs and supplements, PLAs, DIN submissions, regulatory responses, amendments and post-approval activities
- Lead due diligence reviews
- Develop product labeling
- Support product launch planning and advertising/promotional material review
- Serve as principal point of contact for assigned clients and support interactions with Regulatory Authorities
- Lead or support agency meetings, develop briefing materials and provide strategic recommendations on emerging regulatory issues
- Partner with cross-functional development, quality, clinical, medical, commercial and business teams
- Interpret evolving regulatory requirements and translate regulatory intelligence into actionable guidance
- Manage multiple projects against scope, timelines, budgets and quality expectations
- Identify and resolve regulatory risks, issues and competing priorities
- Ensure deliverables meet client requirements, standard operating procedures and quality expectations
- Support proposals, presentations, new-business discussions and client relationship development
- Share expertise through training, mentoring, industry presentations, publications and webinars
- Manage decision-making and conflict resolution for assigned projects and within the team
- Engage in continuous learning and train or coach colleagues
- Perform other duties as assigned
Requirements
What you’ll need- Bachelor’s degree in a life-sciences discipline required
- 5–8 years of direct regulatory affairs experience across the health product lifecycle
- Experience developing pre-market submissions and managing product lifecycle submissions/post-market changes
- Strong working knowledge of Canadian regulatory requirements and Health Canada processes
- Familiarity with relevant ICH requirements
- Experience with FDA, EMA and other international regulatory environments is an asset
- Experience managing or supporting interactions with Regulatory Authorities
- Ability to lead several concurrent client projects while managing timelines, scope, quality and budget considerations
- Strong strategic thinking, analytical judgement and problem-solving capability
- Excellent written, verbal and presentation skills
- Ability to explain complex regulatory issues clearly to varied audiences
- Ability to build trusted relationships with clients and collaborate effectively in multidisciplinary teams
- Strong business acumen and interest in proposals, client development and practice growth
- French-English bilingualism preferred, written and spoken
- Regulatory Affairs Certification (RAC) and prior people-leadership or consulting experience are assets
Benefits
Comp & perks- 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