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Regulatory Affairs Specialist

Il y a 2 mois

Paris, Île-de-France Meet Temps plein
Regulatory Affairs Manager

Meet our client, a leading organization dedicated to advancing innovative healthcare solutions. With a strong emphasis on regulatory excellence, they are committed to delivering safe and effective medicinal products globally.

Key Responsibilities
  • Manage the regulatory lifecycle of OTC and Consumer products, from initial development through post-market activities, ensuring full compliance with relevant regulations and standards.
  • Compile, review, and submit regulatory documents throughout the product lifecycle, including eCTD files (Modules 1 and 3), initial marketing authorizations, variations, notifications, and renewals.
  • Prepare and respond to inquiries from regulatory agencies.
  • Ensure compliance with regulatory requirements, guidelines, and standards.
  • Update regulatory documentation to ensure ongoing company compliance.
  • Participate in discussions with regulatory agencies and manufacturers.
  • Provide regulatory guidance to manufacturers to ensure adherence to relevant standards.
  • Oversee compliance of artwork and packaging, including the preparation of Summary of Product Characteristics and Patient Information Leaflets according to Quality Review Documents (QRD).
  • Work closely with R&D, Quality, and Marketing teams to meet regulatory requirements across the product lifecycle.
  • Offer regulatory advice to project teams during product design, development, evaluation, or marketing.
  • Organize and maintain electronic archives for regulatory affairs documentation.
Requirements
  • Scientific background with a master's degree in pharmaceutics, healthcare, life sciences, or a related discipline.
  • At least 5 years of experience in regulatory affairs within the pharmaceutical industry, preferably with international exposure.
  • Solid understanding of pharmaceutical development and process validation.
  • Demonstrated experience in maintaining regulatory compliance documentation (e.g., technical files, regulatory dossiers).
  • Experience in interactions with regulatory authorities and agencies.
  • Strong planning and time management abilities.
  • Proficient in English (both written and spoken).