Senior Manager CMC, Regional Lifecycle Management

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

Qualifications

• Relevant Bachelor's Degree or higher

• Expertise across a broad spect...