Associate Manager, Regulatory Affairs

Associate Manager, Regulatory Affairs

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Regulatory Affairs Manager

Location:

North America, Canada, Ontario, Markham

Work Location:

Hybrid

What you will do

The Associate Manager, Regulatory Affairs is responsible for ensuring compliance with regulatory requirements, preparing and submitting regulatory documentation, and providing expert advice to project teams. You will coordinate submission timelines, respond to agency inquiries, and manage pre- and post-market product lifecycle submissions:

Key Responsibilities

• Lead cross-functional initiatives to streamline regulatory submission processes, ensuring timely approvals while maintaining compliance with evolving Health Canada standards.
• Develop and implement innovative strategies to anticipate regulatory changes, proactively advising cross-functional teams to mitigate risks and capitalize on opportunities.
• Collaborate with R&D, quality assurance, legal and marketing teams to integrate regulatory considerations early in product development, enhancing market readiness and compliance.
• Ensure full compliance with regulatory agency regulations and interpretative guidance throughout the submission process and post-market life cycle.
• Prepare detailed and accurate responses to inquiries and correspondence from regulatory agencies in a timely manner.
• Collect, organize, and assemble all necessary documentation and data for regulatory submissions in strict adherence to applicable guidelines.
• Review advertising, promotional and artwork in compliance with Health Canada guidelines and regulations.
• Develop and manage submission timelines under the guidance of senior regulatory affairs personnel to ensure on-time delivery.
• Analyze complex regulatory challenges involving intangible variables and provide innovative, data-driven solutions utilizing data to monitor regulatory trends and performance metrics.
• Advise project teams on regulatory strategies and potential impacts to facilitate informed decision-making.
• Mentor junior regulatory specialists, fostering a culture of continuous learning and regulatory excellence within the team.
• Shape the regulatory environment through participation in industry associations and Health Canada consultations

What we are looking for

Required Qualifications

• Bachelor’s degree or equivalent in Life Sciences, Pharmacy, or a related scientific or regulatory field.
• Minimum 6 years of progressive experience in Canadian regulatory affairs, preferably with expertise in cosmetics, natural health products or drugs.
• Demonstrated expertise in interpreting and applying Health Canada regulations and guidelines including preparing, submitting and maintaining regulatory submissions.
• Excellent communication skills, including the preparation of regulatory correspondence and regulatory strategies and articulation to cross-functional teams.
• Ability to manage multiple projects and timelines concurrently under minimal supervision.

Desired Qualifications

• Exceptional ability to interpret and apply Health Canada regulatory guidelines creatively to support innovative product development.
• Strong analytical mindset with proficiency in leveraging regulatory intelligence tools and data to monitor and forecast industry trends.
• Experience working collaboratively with senior regulatory staff and project teams to develop robust regulatory strategies.
• Excellent communication and leadership skills, capable of influencing cross-functional teams and mentoring emerging regulatory professionals.
• Strong analytical skills with the ability to evaluate complex data and intangible variables to solve regulatory challenges.
• Knowledge of the evolving regulatory landscape and participation in industry associations and Health Canada consultations
• Proficiency with regulatory systems and tools (e.g. eCTD, Veeva, RIMs)

What’s in it for you

Annual base salary for new hires in this position ranges:$107,550.00 - $157,550.00

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Kenvue incorporates Artificial Intelligence into our recruitment process to enhance job postings and streamline the sorting and screening of applications, helping attract a qualified candidate pool. Our experienced team will review and select the top applicants, ensuring that human judgment guides our hiring decisions.  For more information, please refer to our Careers Privacy Policy.

Non-Vacancy: This posting does not correspond to an existing vacancy but is part of our proactive recruitment efforts.