Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Location: Mississauga, Ontario (Hybrid model in a modern office)

Salary Range: $100,000 - $120,000 per year, plus bonus and benefits.

Work Authorization: Candidates must be legally authorized to work in Canada at the time of application and throughout employment. Visa sponsorship is not available for this role.

Job Purpose

As a Regulatory Affairs Manager you will manage 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. This includes 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 achieve the objectives in the strategy and achieve agreed upon standards to maximize overall project delivery time and probability of success (POS).
• 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.

Stewardship

• Support end-to-end regulatory compliance of products in remit.
• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
• Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
• Review labelling and formulations for acceptability.
• Maintain high level of knowledge on the science of products within defined portfolio.
• Monitor regulatory trends that could impact portfolio.

Basic 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 (other commercial and technical staff, local senior management, external regulators).
• High ability to manage multiple complex projects and work effectively 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 including NDSs, SNDSs, 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.
• All new parents at Haleon receive 26 weeks of fully paid leave, regardless of gender or sexuality.
• Inclusive, diverse, and collaborative culture.
• Commitment to development and career progression.
• Hybrid model in a modern office located in Mississauga.
• Fitness centre, annual fitness subsidy, and on-site bistro.

Equal Opportunity Employer

Haleon is an Equal Opportunity Employer and prohibits discrimination based on any protected characteristic, ensuring all employees feel they truly belong.