DMF Gatekeeper Lead

DMF Gatekeeper Lead

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 Self Care Operations Inventory and Transformation Programs

Location:

Asia Pacific, China, Shanghai, Shanghai

Work Location:

Fully Onsite

What you will do

China DMF Gatekeeper role in charge of Selfcare product AEP(API, key Excipient, primary Packaging) DMF life cycle management for fixing legacy issues and build disciplined tracking for AEP DMF action plan with supplier for ongoing projects, post market changes and future NPD/I.

What You Will Do 

The [China Selfcare DMF Gatekeeper role] is responsible for [Selfcare product AEP(API, key Excipient, primary Packaging) DMF life cycle management for fixing legacy issues and build disciplined tracking for related action plan with suppliers]:

Key Responsibilities

• [Manage OTC products DMF tracking for API, key Excipient, primary Packaging in life cycle management view. Act as key contact window for Kenuve China team to interface with supplier for DMF action plan from DMF dossier preparation, submission, all the way to approval. ]
• Act as key contact window from China team for API, key Excipient, primary Packaging materials changes from oversea Kenvue plant, EM or material supplier. Ensure oversea partners follow the standard process for impact evaluation and coordinate China internal teams for assessing FG impact level. Track oversea AEP changes to ensure task delivery 100% on time, minimize prebuild impact and avoid any business interruption.
• For NPD/I projects with materials with insufficent AEP DMF readiness, be responsible for validating supplier action plan for getting DMF-A approval, timeline feasibility, check any missing, risk management etc. Closely track supplier DMF application progress to ensure milestones on time delivery and all approval completion before Registration batch.]
• Manage Agency for detailed DMF registration need for oversea suppliers even with zero capability for China DMF registration if needed, calibrate solution from agency, deliver aligned information with internal Kenvue partners. Monitor agency service level and provide feedback to procument.
• Act as key representative to attend AP AEP council for China new DMF non-A AEP materials life cycle govenance. Proactively  work with RA, R&D, Procument, RMC, SQM, QA, TO etc to bring upfront of DMF non-A risk, option study, action plan proposal and meanwhile link this with NPD and material strategy to position Kenvue competitiveness with efforts for DMF. Build robust life cycle managment of AEP DMF for selection, qualification, monitoring and disengagement with strong collaboration with procument and SQM.
• Proactively identify supply risks and mitigation plan with good insights of OTC regulation update and supplier industry trend.]

What We Are Looking For

Required Qualifications

• 5+yrs Experience in Pharmacutical industry with insights of AEP DMF regulation, drug product dossier
• Familiar with AEP DMF regulation requirement difference with US/EU, industry practice
• Clear logic and familiar with action plan tracking with multi-suppliers, well manage supporting agency
• Strong ownership for task on time delivery, good communication, advocacy skillset
• Strong stakeholder management skillset and good collaboration with x-functions
• Program and Project management experience preferred

Desired Qualifications

• Bachlor degree and above, Pharm / Medical background preferred
• Good understanding/expertise of China DMF for API, key Excipent, primary Packaging
• Experience of working on product launches and life cycle management for both locally manufactured and imported products and/or materials  
• Proven experience of tackling multiple high complexity situations, supplier action plan management
• PMP/FPX certifed prefered
• Good stakeholder management with cross-functions, regoinal and global contacts
• Strong ownership, daring spirit and outside in focus
• Fluent in English

What’s In It For You

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups 

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