Regulatory Affairs Manager

il y a 5 jours


Paris, Île-de-France Meet Temps plein

Meet the Regulatory Affairs Manager, a key role in ensuring the compliance of medicinal products globally. This position requires a strong understanding of regulatory excellence and a commitment to delivering safe and effective products.

Key Responsibilities:

  • 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.
  • Track and manage timelines for license variations, notifications, and renewal approvals.
  • 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.
  • Stay informed on current national and international legislation and guidelines.
  • Organize and maintain electronic archives for regulatory affairs documentation.

Candidate 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.
  • Thorough knowledge of relevant European guidelines and legislation.
  • Proficient in English (both written and spoken).
  • Personality traits: determined, persuasive, assertive, and communicative.


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