Regulatory Affairs CMC Manager

Kenvue is currently recruiting for a:
Regulatory Affairs CMC Manager
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 Global & EMEA Regulatory Affairs OTC
Location:
Europe/Middle East/Africa, Sweden, Skane, Helsingborg
Work Location:
Hybrid
What you will do
End-to-end responsibility for Module 3/CMC new product development and life cycle management
Acts as regulatory CMC lead in new product development projects with responsibility for regulatory CMC strategy development and deployment
Leads a team of regulatory affairs CMC product owners with responsibility for Module 3/CMC maintenance ensuring the success of life cycle management activities and roll-out of existing products
Provides technical leadership and expertise to cross-functional R&D partners and life cycle management teams to support development of fit for purpose CTD Module 3/CMC documentation for marketing authorization applications and variations globally
Develop strong partnerships with Regulatory Affairs partners, R&D, Marketing and Supply Chain
Represents the Regulatory Affairs CMC function as appropriate in various regulatory and cross-functional teams and technical fora
Creates an environment of operational excellence through regulatory expertise, management of CMC product owners and collaboration with cross-functional teams
​Knowledge and skills
Relevant Bachelor's Degree or higher
10+ years experience from regulatory affairs and/or pharmaceutical product development
Expertise across regulatory classifications including medicinal products and medical devices as it relates to pharmaceutical CMC regulatory affairs
Knowledge of regulatory frameworks globally as it concerns pharmaceutical product development and CMC requirements
Experienced in developing and maintaining Module 2.3 and 3 and providing guidance to cross-functional partners in authoring CTD documents
Strong project and people management skills
Highly collaborative and strong sense of ownership
Proficiency in English
Background checks in the recruitment process
As a final candidate in our recruitment process, you may be subject to a background check. This process is important for us to ensure the quality of our recruitment process.
As part of this, it is important that we encourage you to make sure that the information in your CV is correct before submitting your application to us.
To carry out these background checks, we use a background check company. Different checks may be carried depending on the position that you are applying for. This could be, for example:
Reference checks
CV-validation
Financial checks
Litigation checks, including criminal cases
The background check company is an independent data controller for any personal data that they will process during the check, and if you have any questions about the processing, you may turn to the background check company.
Due to our business activities and daily operations, we may also carry out drug tests as part of our recruitment process.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.