Regulatory Affairs Manager
$100,000–$120,000 year
Hybrid · Mississauga, Ontario, Canada
Job Summary
Regulatory Affairs Manager to lead end-to-end regulatory activities for the assigned portfolio, shaping practical regulatory strategies that support business and consumer needs while partnering closely with internal and external stakeholders. Responsibilities include representing Regulatory Affairs on projects, reviewing formulas for local acceptability and claims development, preparing and submitting high-quality regulatory submissions for Health Authority, responding to regulatory queries, engaging with authorities to expedite approvals, stewarding regulatory compliance, developing robust claims/advertising within regulations, identifying regulatory risks and proposing solutions, reviewing labelling and formulations for acceptability, and monitoring regulatory trends to inform strategy. Hybrid work model in Mississauga, with collaboration across commercial, Global Reg, and R&D teams.
Required Qualifications
- Minimum of 8 years of progressive experience in Regulatory Affairs within the pharmaceutical/consumer health industry
- Post-secondary degree or equivalent in Life Sciences, Pharmacy or related scientific field
- Demonstrated expertise in interpreting and applying regulations and guidelines
- Demonstrated ability to interface effectively with internal and external stakeholders
- High ability to manage multiple complex projects and work effectively independently and as part of a cross-functional team
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