Regulatory Affairs CMC Manager

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

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.