Regulatory Affairs Director Healthcare

il y a 2 jours


Paris, Île-de-France Meet Temps plein
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Meet. As a key member of our organization, you will be responsible for ensuring the regulatory compliance of our medicinal products globally.

Key Responsibilities
  • Regulatory Lifecycle Management: Manage the regulatory lifecycle of OTC and Consumer products, from initial development through post-market activities, ensuring full compliance with relevant regulations and standards.
  • Document Compilation and Submission: Compile, review, and submit regulatory documents throughout the product lifecycle, including eCTD files (Modules 1 and 3), initial marketing authorizations, variations, notifications, and renewals.
  • Regulatory Agency Engagement: Prepare and respond to inquiries from regulatory agencies, ensuring compliance with regulatory requirements, guidelines, and standards.
  • Regulatory Documentation: Update regulatory documentation to ensure ongoing company compliance, and participate in discussions with regulatory agencies and manufacturers.
  • Regulatory Guidance: Provide regulatory guidance to manufacturers to ensure adherence to relevant standards, and oversee compliance of artwork and packaging.
  • Team Collaboration: Work closely with R&D, Quality, and Marketing teams to meet regulatory requirements across the product lifecycle, and offer regulatory advice to project teams during product design, development, evaluation, or marketing.
  • Documentation Management: Organize and maintain electronic archives for regulatory affairs documentation.
Requirements
  • Scientific Background: Master's degree in pharmaceutics, healthcare, life sciences, or a related discipline.
  • Regulatory Experience: At least 5 years of experience in regulatory affairs within the pharmaceutical industry, preferably with international exposure.
  • Regulatory Knowledge: Solid understanding of pharmaceutical development and process validation, and demonstrated experience in maintaining regulatory compliance documentation.
  • Communication Skills: Experience in interactions with regulatory authorities and agencies, and strong planning and time management abilities.
  • Language Skills: Proficient in English (both written and spoken).


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