Regulatory Affairs Strategist

il y a 3 semaines


Paris, Île-de-France Apsida Life Science Temps plein

Apsida Life Science is seeking a highly experienced Regulatory Affairs Consultant with a strong background in regulatory strategy and new submissions in LATAM, APAC, or International markets.

The successful candidate will support the global regulatory strategies for product registrations, ensuring compliance with local regulations while optimizing timelines for approvals.

The key responsibilities include:

Core Responsibilities
  • Develop and implement comprehensive regulatory strategies for new submissions, amendments, and product life cycle management across LATAM, APAC, or international markets.
  • Prepare, review, and manage the submission of regulatory documents for product registrations, variations, amendments, and renewals, ensuring all documentation complies with the regulatory requirements of target markets.
  • Ensure regulatory compliance across regions and maintain a robust knowledge of international regulations, including those issued by agencies such as ANVISA, COFEPRIS, INVIMA, FDA, EMA, TGA, HSA, CFDA, etc.
  • Stay current on evolving regulatory landscapes, guidance, and practices in international markets, especially in LATAM and APAC regions, and assess the impact of changes on ongoing and future regulatory submissions.
  • Collaborate with cross-functional teams to ensure regulatory compliance.
  • Serve as a point of contact for health authorities.

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