Regulatory Operations and Company Core Data Sheet [CCDS] Supervisor

Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation.

Job Description - Regulatory Operations and Company Core Data Sheet [CCDS] Supervisor (2507032905W)

Regulatory Operations and Company Core Data Sheet [CCDS] Supervisor

This position reports to David Lutness and is based at Sao Paulo, Brazil.

Who we are

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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and brilliant people, 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 the life of 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.

What you will do

The Regulatory Operations and CCDS Manager is responsible for day-to-day regulatory operations and execution of program initiatives. This includes overseeing compliant regulatory submissions in coordination with cross-functional teams. This key role will enable focus and growth across our regulatory organization by enhancing and improving on digital-first principles to address aspects of our business related to CCDS and related documentation.

Key Responsibilities

1. Oversee regulatory submissions (IND, NDA, BLA, MAA, variations, amendments, etc.)
2. Ensure compliance with global health authority regulations
3. Manage publishing, validation, and submission processes for regulatory documents
4. Coordinate with cross-functional teams (Regulatory Affairs, Clinical, Quality, CMC, IT, etc.)
5. Proactively monitor regulatory changes and update internal processes and personnel accordingly
6. Train and mentor junior team members in regulatory operations best practices

Qualifications

What we are looking for

Required Qualifications

1. Demonstrated application of knowledge of regulatory submission standards (e.g., FDA, EMA, ICH guidelines)
2. Proficiency in eCTD publishing tools (e.g., Veeva Vault RIM, Lorenz DocuBridg, GlobalSubmit, Extedo)
3. Experience with Regulatory Information Management Systems (RIMS)
4. Experience and familiarity with document control systems and regulatory submission portals (e.g., FDA ESG, EMA CESP)
5. CCDS Creation and Maintenance
6. Proficient in English both written and orally.

Desired Qualifications

1. Bachelor’s or advanced degree in relevant Life Sciences, Pharmacy, Chemistry, or Regulatory Affairs
2. 10+ years of experience in regulatory operations within the CPG, Pharmaceutical, biotech, or medical device industry
3. Proven project and program management
4. An eye and attention to detail and ability to navigate and deliver in tight timelines
5. Effective communicator ability to navigate large teams across multiple countries
6. Problem-solving mindset with a proactive approach

What’s in it for you

1. Annual base salary for new hires in this position takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.
2. Paid Company Holidays, Paid Vacation, Volunteer Time & More!
3. Learning & Development Opportunities
4. Employee Resource Groups

*Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

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