Regulatory Affairs Manager
$100k - $120k per yearHaleon
Regulatory Affairs Manager – Responsible for managing 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.
Key Responsibilities
- Represent Regulatory Affairs on assigned projects, providing guidance on regulations and developing regulatory strategies, including review of formulas for local acceptability and claims development.
- Collaborate with global and local stakeholders (commercial, Global Reg, R&D, etc.) to ensure regulatory contributions meet the objectives of the strategy and agreed standards to maximize project delivery time and probability of success.
- Prepare and submit high‑quality regulatory submissions for health authorities and respond effectively to health authority queries.
- Participate in interactions (meetings, teleconferences) with regulatory authorities to seek guidance and expedite approval of pending applications.
- Steward end‑to‑end regulatory compliance of products in remit, supporting the development of the strongest claims, advertising, and promotion possible within the regulations and ensuring risks are appropriately addressed and communicated.
- Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility.
- Review labelling and formulations for acceptability.
- Maintain a high level of knowledge on the science of products within the defined portfolio.
- Monitor regulatory trends that could impact the portfolio.
Basic Qualifications
- Minimum 8 years 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 (commercial, technical staff, local senior management, external regulators).
- High ability to manage multiple complex projects and work independently and as part of a cross‑functional team.
Preferred Qualifications
- 5 years of experience in OTC or Consumer Health.
- Knowledge of submission requirements and timelines related to drugs and natural health products (NDS, SNDS, DINAs, PLAs).
- Post‑graduate Regulatory Affairs Certificate/Diploma, RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD.
- Proficiency with regulatory systems and tools (e.g., Veeva RIM, eCTD).
Benefits
- Competitive compensation and annual bonus package.
- Comprehensive and flexible benefits program from day 1.
- Defined contribution pension plan with employer contribution.
- Optional Haleon Savings Plan with employer matching.
- 26 weeks of fully paid leave for new parents, regardless of gender or sexuality.
- Inclusive, diverse, collaborative culture.
- Commitment to development and career progression.
- Hybrid model in a modern office located in Mississauga.
- On‑site fitness centre, annual fitness subsidy, and bistro onsite.
Salary & Work Authorization
Salary Range: $100,000 – $120,000 base salary plus bonus and benefits.
Candidates must be legally authorized to work in Canada at the time of application. Visa sponsorship is not available for this role.
Equal Opportunities
Haleon is committed to mobilising our purpose in a way that represents diverse consumers and communities. We create an inclusive culture where all employees feel they truly belong, and we value different backgrounds and views.
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