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DMF Gatekeeper Lead

职位职能:
发布日期:
结束日期:
ID:
2507036292W

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Kenvue 目前正在招聘 a:

DMF Gatekeeper Lead

我们做什么

Kenvue,我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础,植根于科学,是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成,他们的职场文化中,每个声音都很重要,每一个贡献都受到赞赏。 我们热衷于洞察, 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心,成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本,热切关怀,以科学赢得信任,以勇气解决——有绝佳的机会等着您!加入我们,塑造我们和您的未来。有关更多信息,请单击 here.

Role reports to:

Director Self Care Operations Inventory and Transformation Programs

位置:

Asia Pacific, China, Shanghai, Shanghai

工作地点:

完全现场

你会做什么

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 

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