Regulatory Affairs Expert

il y a 3 semaines


Paris, Île-de-France ProductLife Group Temps plein

Regulatory Affairs Expert

We are currently seeking a Regulatory Affairs Expert to support our esteemed clients in the pharmaceutical sector. This role is pivotal in managing regulatory functions and ensuring compliance with local and international regulations.

Key Responsibilities:

  • Facilitate the gathering of data related to regulatory obligations and assess the regulatory implications of change controls.
  • Oversee the activities of external partners responsible for the preparation of variation submissions in accordance with applicable laws and local standards.
  • Track the progress of variation submissions and their approval by health authorities, adhering to established timelines.
  • Manage and update packaging materials, ensuring modifications are validated and compliant.
  • Extract, validate, and maintain information within regulatory databases.
  • Compile and draft reports summarizing project developments.
  • Maintain dashboards and ensure proper electronic documentation practices.

Qualifications:

  • A degree in Pharmacy is required.
  • A qualification in Regulatory Affairs is advantageous.

Experience:

  • A minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry is essential.

Skills:

  • In-depth knowledge of French regulatory frameworks.
  • Familiarity with European regulations is a plus.
  • Proficiency in both English and French is necessary for effective communication.
  • Able to thrive in a dynamic work environment.
  • Possess an entrepreneurial mindset and the ability to facilitate change.
  • Strong stress management capabilities.

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