Manager, CMC Regulatory Affairs

Manager, CMC 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:

DIRECTOR REGULATORY AFFAIRS

Location:

North America, Canada, Ontario, Markham

Work Location:

Hybrid

What you will do

The Manager, CMC Regulatory Affairs (RA), is responsible for developing regulatory strategies and providing guidance to R&D and commercial teams on compliance and ensuring timely approval of products. You will oversee preparation of regulatory filings and collaborate with agencies and management to support product approvals for Kenvue products:

Key Responsibilities

• Prepares CMC regulatory product strategies for Kenvue products. Prepares and manages regulatory submissions to Health Canada, including new applications and amendments, annual reports, supplements and variations and responds to regulatory information.

• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.

• Ensure the timely submission of CTAs, NDS, amendments, and supplements; and NHP applications for assigned products/projects.

• Review and prepare responses to Health Canada  CMC questions, and pre-submission meeting packages.

• Develop strategies for CMC Health Canada  meetings. Manages preparation for agency meetings, and content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.

• Manage products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.

• Represents RA CMC on cross-functional teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.

• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization.

• Develops, implements, and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC.

• Serve as the Regulatory Affairs representative on project teams; manage the progress of projects by providing direction, solutions, and feedback to the teams.

• Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization, may include formal supervisory responsibilities.

What we are looking for

Required Qualifications

• Bachelor’s degree in relevant scientific or regulatory discipline.

• Minimum 8 years of progressive experience in drug regulatory affairs with 5 years of CMC drug regulatory affairs, preferably  in the preparation and submission of drug applications to Health Canada

• Experience reviewing/authoring Module 3 for eCTD submissions.

• Demonstrated expertise in regulatory compliance, submission processes, and interactions with regulatory agencies, including Health Canada.

• Strong oral and written communication and organizational skills to effectively manage documentation and stakeholder interactions.

• Proven ability to interpret and apply regulatory guidelines and standard operating procedures to ensure compliance and expedite approvals.

• Demonstrated success with direct people management.

Desired Qualifications

• Master’s degree or equivalent advanced degree in a relevant scientific or regulatory discipline.

• OTC drug, NHP, medical device and cosmetic CMC RA experience.

• Proven expertise in navigating global regulatory frameworks with a track record of successful product registrations across multiple regions.

• Experience leading health authority meetings and interactions.

• Experience working with industry counterparts and trade association committees and task groups.

• Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others

• Strong leadership skills with experience managing cross-functional teams and coordinating regulatory activities.

• Strong strategic thinking and communication skills, capable of translating complex regulatory requirements into actionable business solutions.

Kenvue Canada's corporate office is currently located in Markham, ON but is scheduled to move to North York (Yonge and Sheppard area) in or around Q3 2026.

What’s in it for you

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.

Vacancy: This job posting is for an existing, currently vacant position.