Regulatory Affairs Strategist
il y a 3 semaines
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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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
Paris, Île-de-France SGS Société Générale de Surveillance SA Temps pleinJob Title: Associate Regulatory AffairsWe are seeking a highly skilled Associate Regulatory Affairs professional to join our team at SGS Société Générale de Surveillance SA. As a key member of our Regulatory Affairs team, you will play a crucial role in supporting our various departments in navigating banking supervision and related regulations.Key...
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il y a 4 semaines
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il y a 4 semaines
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il y a 4 semaines
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