Senior Manager CMC, Regional Lifecycle Management

Job Description

Kenvue is currently recruiting for-

Senior Manager CMC & Regional Lifecycle Management

Location- London

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 that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact 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.

The Senior Manager CMC & Regional Lifecycle Management leads a team responsible for the post approval lifecycle management of the regional Self Care portfolio across the EMEA region .

Responsibilities-

• Develop and execute global CMC and post approval regulatory strategy with a focus on regulatory compliance
• Identify the required documentation and any content, quality and/or timelines issues for global/regional submissions (as relevant) and support the delivery of approved technical source documents in accordance with project timelines.
• Oversee authoring and/or review of high-quality CMC/core labelling documentation for regulatory submissions, applying agreed global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and publishing requirements.
• Deploy risk management strategies for product lifecycle maintenance, proactively communicate regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stake holders. Represent department in cross-functional project teams as appropriate.
• Lead, prepare and communicate CMC & Labelling Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate as appropriate.
• Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans.
• Create an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve regulatory objectives & compliance
• Develops strong partnerships with R&D, Franchise, Operations and local regulatory representatives.
• Represents the Regulatory Affairs function as appropriate in Self Care Franchise, functional and business Leadership teams
• Relevant Bachelor's Degree or higher
• Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory
  
  

solutions throughout the product lifecycle.

• Strong knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance
• Strong knowledge in handling post approval changes of solid oral, nasal sprays and other dosage forms in addition to manufacturing and regulatory data requirements for managing Global post approval submissions.
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
• Leadership and coaching skills with experience of people development
• Proficiency in English
  
  

What’s In It For You

• Competitive Benefit Package
• Learning & Development Opportunities
• Kenvuer Impact Networks
  
  

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

Primary Location

Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Job Function

Regulatory Affairs

Job Qualifications

Qualifications