Senior Associate, CMC Regulatory Affairs

Senior Associate, 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:

Associate Director, Regulatory Affairs

Location:

North America, Canada, Ontario, Markham

Work Location:

Hybrid

What you will do

The Sr. Associate, CMC Regulatory Affairs supports the development and execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for assigned products. Working under the guidance of senior regulatory professionals, you will contribute to regulatory submissions and help ensure compliance with Health Canada requirements across the product lifecycle.

Key Responsibilities

• Support the preparation, compilation, and maintenance of CMC regulatory submissions to Health Canada, including new applications, amendments, annual reports, and supplements.
• Assist in the preparation and review of CMC documentation, including Module 3 components for eCTD submissions.
• Prepare responses to Health Canada CMC questions and information requests under supervision.
• Contribute to regulatory strategies by gathering, analyzing, and summarizing regulatory and technical information relevant to assigned products.
• Assist with change control activities by  reviewing and assessing CMC changes for regulatory impact.
• Participate as a Regulatory Affairs CMC team member on cross‑functional project teams, providing regulatory input as needed.
• Maintain awareness of evolving Health Canada regulations, guidelines, and policies, and share relevant updates within the team.
• Support the development and maintenance of internal regulatory documentation, processes, and procedures.

What we are looking for

Required Qualifications

• Bachelor’s degree in a relevant scientific or regulatory discipline.
• Minimum 2 years of experience in regulatory affairs, pharmaceutical development, or a related regulated industry, with exposure to CMC activities preferred.
• Basic understanding of Health Canada regulatory requirements and drug submission processes.
• Familiarity with CMC documentation and regulatory submission formats (e.g., eCTD), with hands-on experience considered an asset.
• Strong written and verbal communication skills, with attention to detail and good organizational skills.
• Ability to work collaboratively in a cross-functional team environment and manage multiple tasks with guidance.

Preferred Qualifications

• Experience supporting regulatory submissions for pharmaceuticals, OTC drug products, or Natural Health Products.
• Exposure to regulatory interactions or responses to health authority questions.
• Interest in building a career in CMC Regulatory Affairs within a global organization.

What’s in it for you

Annual base salary for new hires in this position ranges:$81,000.00 - $129,950.00

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.

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