Regulatory Affairs Specialist

What We Do

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®. Science is our passion; care is our talent.

Location:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire.

Work Location:

Hybrid.

Reports To:

Senior CMC Manager.

The Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products. Projects may include compilation and submission of applications (post-approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.

• Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.
• Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
• Prioritizes, plans and monitors allocated projects against defined timelines.
• Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.
• Ensures that all assigned products comply with local regulatory and quality system requirements.
• Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
• Identifies & initiates local process improvement opportunities and manage changes as required.
• Assists in the preparation for internal and external audits and inspections in collaboration with others.
• Partner with other critical functions to execute plans to address crises and other sensitive issues.

Required Qualifications

• Relevant Bachelor's Degree or higher
• 4+ yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).
• Good attention to details.
• Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
• Good interpersonal skills; able to build effective personal networks internally and externally.
• Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
• Strong organizational and time management skills with an ability to work under pressure.
• Able to work effectively in a multi-cultural, highly matrixed organization.
• Proficiency in English

Desired Qualifications

• Knowledge of consumer healthcare environment and product development
• Understanding of processes and departments within a healthcare company
• Effective time and organisation management

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.