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Manager Regulatory Affairs - SelfCare

ISSY LES MOULINEAUX
il y a 15 heures

Regulatory Affairs Manager – Self‑Care

Role reports to: Global Ingredient Management Director

Location: Europe/Middle East/Africa, France, Haute‑de‑Seine, Issy Les Moulineaux

Work Location: Hybrid

Position Base: Issy‑les‑Moulineaux, France or Reading, United Kingdom. This position is reporting to EMEA Regulatory Science & Advocacy Director.

Role Overview

As Regulatory Affairs Manager – Self‑Care, you will be part of the EMEA Regulatory Science & Advocacy team, lead regulatory intelligence, shape regional policy positions, engage across the self‑care ecosystem, and ensure internal alignment. You provide clear, actionable insights to support strategic decisions in an evolving regulatory landscape for self‑care products.

Key Responsibilities

Regulatory Intelligence & Foresight

  • Monitor regulatory and scientific developments from EMA, HMA, CMDh, the European Commission, and national competent authorities.
  • Identify emerging changes related to EU pharmaceutical legislation revision, ingredients, switches, labeling, pharmacovigilance, digital health, advertising and claims initiatives impacting self‑care products.
  • Anticipate regulatory trends, identify risks and opportunities, and provide actionable regulatory insights to internal stakeholders.

Regulatory Policy Strategy & Development

  • Build regional regulatory positions on emerging self‑care regulations and contribute to company‑wide policies and advocacy priorities.
  • Coordinate internal input to consultations, industry discussions, and legislative initiatives.
  • Support the development of science‑based positions and pragmatic regulatory approaches.
  • Collaborate with global and regional teams to ensure consistency and alignment of regulatory strategies.

External Advocacy & Representation

  • Participate in trade associations, technical committees, and expert forums.
  • Build constructive relationships with regulatory authorities, scientific committees, and institutional stakeholders.
  • Promote science‑based and pragmatic regulatory approaches.

Internal Leadership & Alignment

  • Serve as a key regulatory partner for R&D, Medical, Safety, Quality, Marketing, Legal, Sustainability, and Commercial teams.
  • Communicate complex regulatory changes clearly and pragmatically to support decision‑making.
  • Provide impact assessments and strategic recommendations to strengthen organizational readiness and compliance.
  • Drive alignment across functions and support capability building on evolving self‑care regulations.

Qualifications

  • Relevant bachelor’s degree or higher in Regulatory Affairs, Life Sciences, Pharmacy, Law, Public Policy, or related field.
  • Minimum 10 years of experience in regulatory affairs within the pharmaceutical, OTC, or self‑care industry.
  • Strong understanding of EU regulatory processes and interactions with competent authorities.
  • Experience engaging with trade associations, health authorities, or industry working groups.
  • Strong communication, stakeholder management, and cross‑functional leadership skills.
  • Fluency in English.

EEO Statement

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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