
Regional Regulatory Affairs Expert
4 days ago
Coverage: The Asia region.
This is a key role in shaping regulatory strategies and ensuring successful product registrations across the Asia region. It involves acting as the link between global regulatory affairs, local partners, and health authorities to bring life-changing products to market efficiently and compliantly.
Main Responsibilities:
- Lead and support regulatory submissions across the Asia region, ensuring full compliance with local and country-specific requirements.
- Serve as the primary liaison between global regulatory affairs, in-country partners, and health authorities.
- Monitor regulatory changes in the region and provide timely updates to global teams.
- Collaborate closely with internal cross-functional teams including country managers, QA, and medical affairs.
- Support product lifecycle management and contribute to strategic regulatory planning.
- Maintain and update internal regulatory databases and systems.
- Facilitate effective communication and alignment with local agents and authorities.
Key Requirements:
- A degree in life sciences, regulatory affairs, pharmacy, or a related field.
- A minimum of 6 years of experience in regulatory affairs roles, with proven multi-market coverage in Asia.
- Strong knowledge of country-specific regulatory requirements for biologics or pharmaceuticals.
- Familiarity with electronic regulatory systems and databases.
- Excellent written and verbal communication skills in English.
- Strong project management capabilities and a collaborative mindset.
This role is ideal for someone who thrives in a global matrix setting, is passionate about regulatory science, and wants to contribute to meaningful healthcare outcomes across diverse markets.
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