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Regulatory Affairs Manager

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

Senior Manager, Regulatory Affairs, CMC

Located: High Wycombe, UK (Hybrid)

Who We Are

Kenvue is a global leader in the development and manufacturing of everyday care products. Our team of 22,000 diverse and brilliant people is passionate about insights, innovation, and delivering the best products to our customers. We put people first, care fiercely, earn trust with science, and solve with courage.

What You Will Do

The Senior Manager, Regulatory Affairs, CMC will lead a team responsible for developing CMC/technical regulatory strategies across the EMEA region. This role will provide regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.

Key Responsibilities

Regulatory Strategy

• Develop and implement regulatory strategies to ensure compliance with regional regulations.

• Provide regulatory input and technical guidance on regional regulatory requirements to product development teams.

• Participate in cross-functional project teams to define RA resources, development program requirements, and risks.

• Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.

Regulatory Compliance

• Maintain awareness of current regulations and anticipate implications and opportunities due to changes in the relevant regulatory environments.

• Communicate changes to appropriate management and cross-functional experts as necessary.

• Ensure that all products comply with local regulatory and quality system requirements.

Regulatory Advocacy

• Monitor the regulatory environment and provide assessments of the impact of new and changing regulations on the company's areas of interest.

Team Management

• Provide technical and leadership development & coaching to build a high-performing team.

• Evaluate deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.

Additional Responsibilities

• Partner with the business to deliver regulatory outcomes to enable committed business plans within the area of responsibility.

• Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice.

• Manage work groups and provide direction.

• Provide day-to-day instructions and suggested training activities to direct reports.

• Apply organizational understanding and awareness in decision-making.

• Use effective communication and employ influencing skills to continue to grow key relationships with internal/external contacts.

• Build and guide the team and develop direct reports.

• Recruit high-caliber professionals and contractors to strengthen the business talent.

• Represent the Senior Director/Director Regulatory Affairs (CMC) as delegate on request.