About the role
The Senior Regulatory Associate supports and leads regulatory activities across Reckitt’s Canadian portfolio, as required, developing practical regulatory strategies that support business and consumer needs while ensuring compliance with applicable Canadian regulatory requirements. The role partners with local and global teams to support innovation, commercialization, product lifecycle management and ongoing compliance across multiple product categories. Strong Canadian over-the-counter (OTC) drug regulatory experience is central to this position. Responsibilities and priorities may evolve based on business needs.
Your responsibilities
Represent Regulatory Affairs on designated projects and business initiatives, providing regulatory guidance and recommending practical strategies for product development, commercialization and lifecycle management.
Provide regulatory expertise across brands and product categories as needed; lead designated regulatory activities and coordinate priorities, milestones and deliverables.
Partner with local and global cross functional teams to support project objectives, timely delivery and compliant business outcomes.
Assess regulatory requirements and recommend solutions independently within defined responsibilities; escalate significant risks, complex strategies and decisions for management review and approval.
Develop and recommend submission approaches, with particular emphasis on Canadian OTC drugs, and prepare, review and coordinate high-quality submissions, notifications and post-approval changes, as applicable.
Coordinate responses to Health Canada and other relevant authorities, participate in regulatory interactions as appropriate, and maintain accurate submission, licensing and regulatory records.
Assess formulations, ingredients, indications, labelling, packaging and promotional claims for Canadian acceptability and compliance; support robust, scientifically substantiated claims within applicable requirements.
Support regulatory compliance throughout the product lifecycle, including changes, reformulations, safety-related activities and post-market obligations, as applicable.
Identify and communicate regulatory risks and business impacts, recommend proportionate mitigation measures and support improvements to regulatory procedures and work practices.
Monitor relevant Canadian regulatory developments, assess potential portfolio impacts and translate requirements into actionable advice for cross-functional partners.
Share technical knowledge with colleagues and support appropriate engagement with regulators, trade associations and other external stakeholders.
The experience we're looking for
Post-secondary diploma in Regulatory Affairs; BSc degree in the natural sciences or equivalent preferred.
5–8 years of progressive regulatory affairs experience in the pharmaceutical, OTC drug or consumer health industry.
Demonstrated hands-on Canadian OTC drug regulatory experience, including Health Canada submissions, product licensing, labelling and lifecycle management.
Strong working knowledge of the Food and Drugs Act, Food and Drug Regulations and applicable Health Canada guidance for OTC drugs.
Experience evaluating product formulations, claims, labelling and promotional materials against regulatory requirements.
Ability to interpret complex requirements, assess regulatory risks and recommend practical solutions, with sound judgment about escalation.
Strong project management, organization, written and verbal communication, and cross-functional stakeholder influencing skills.
Ability to work with uncertainties and develop innovative solutions to complex regulatory challenges
Impactful verbal and written communication skills
Strong negotiating, influencing and interpersonal skills
Results oriented, entrepreneurial and self-motivated
Proficiency in French language is an asset
The skills for success
Task Execution Under Pressure, Makes strategic Business Decisions, Business accumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, Creative Direction, R&D, Change Leadership, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Relationship Management, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes, Digital transformation for R&D, Quality and Manufacturing.
What we offer
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
Salary ranges
CAD $97,000.00 - $145,000.00
Equality
We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
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