Global Regulatory CMC Lead – Pharma

Kenvue; Reading; Hybrid; GBP 69,000 - 100,000; Full time

Job summary

Kenvue seeks an experienced Regulatory Affairs CMC Manager to lead end-to-end Module 3/CMC activities for new product development and lifecycle management across global markets. You will drive regulatory CMC strategy, mentor product owners, and partner with R&D, marketing and supply chain to ensure compliant submissions and timely approvals.

You will oversee cross-functional teams, provide technical leadership on CTD documentation, and advance global CMC initiatives while upholding high

Qualifications

• 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.

Responsibilities

• 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

Skills

Regulatory strategy

CTD expertise

Project management

People management

English proficiency

Education

Bachelor's degree or higher

Job description

Kenvue seeks an experienced Regulatory Affairs CMC Manager to lead end-to-end Module 3/CMC activities for new product development and lifecycle management across global markets. You will drive regulatory CMC strategy, mentor product owners, and partner with R&D, marketing and supply chain to ensure compliant submissions and timely approvals.

You will oversee cross-functional teams, provide technical leadership on CTD documentation, and advance global CMC initiatives while upholding high