Senior Regulatory Specialist – Self Care
Reports to:
EMEA Regulatory Science & Advocacy Director
Location:
Europe/Middle East/Africa (France, Normandy, Val-de-Reuil) – Hybrid; Optionally Reading, United Kingdom.
Role Overview
As a Senior Regulatory Affairs Specialist – Self Care, you will be part of the EMEA Regulatory Science & Advocacy team and support regulatory intelligence, policy development, external engagement, and cross‑functional alignment. You will provide clear regulatory insights to help guide strategic decisions in the evolving EU self‑care environment.
Key Responsibilities
* Regulatory Intelligence & Foresight
o Monitor regulatory developments from EMA, HMA, CMDh, the European Commission, and national competent authorities.
o Track topics such as EU pharmaceutical legislation revision, Rx‑to‑OTC switches, labelling and packaging rules, pharmacovigilance, benefit‑risk considerations, and quality standards.
o Identify potential impacts on products, portfolios, processes, and strategic plans.
o Provide concise analyses to support business preparedness.
* Regulatory Policy Contribution
o Contribute to company positions on EU regulatory and policy initiatives affecting the self‑care landscape.
o Coordinate internal inputs to public consultations, draft guidelines, and legislative proposals.
o Ensure EMEA‑specific insights are reflected in global regulatory and policy discussions.
o Support development of advocacy materials and briefing documents.
* External Advocacy & Representation
o Participate in industry association working groups and relevant regulatory or policy platforms.
o Support interactions with regulators, policymakers, and institutional stakeholders.
o Contribute scientific and regulatory expertise to help shape proportionate, consumer‑centric, and innovation‑friendly frameworks for OTC medicines.
* Internal Leadership & Alignment
o Collaborate with Regulatory Affairs, Medical, Quality, Legal, Government Affairs, R&D, and Commercial teams.
o Communicate regulatory changes clearly and pragmatically.
o Provide regulatory assessments to support decision‑making and internal governance processes.
o Help ensure organizational readiness for evolving regulatory expectations.
Qualifications
* Relevant bachelor’s degree or higher in Regulatory Affairs, Life Sciences, Pharmacy, Law, Public Policy, or related field.
* Minimum 5 years of experience with EU regulatory frameworks for self‑care and OTC products.
* Strong understanding of EU regulatory processes and interactions with competent authorities.
* Proven ability to interpret complex regulatory texts and translate them into actionable guidance.
* Excellent communication, synthesis, and stakeholder engagement skills.
* Fluency in English.
Benefits
* Competitive Benefit Package
* Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
* Extensive Learning & Development Opportunities
* Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status or disability. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
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