RAS Senior Associate
We are Reckitt
Research & Development
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
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
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