
Senior Regulatory Affairs Professional
4 days ago
Job Opportunity
A Senior Regulatory Affairs Specialist will be responsible for providing comprehensive regulatory support across India and APAC regions.
- Regulatory Support & Product Lifecycle Management
- Maintain and update product registrations and licenses in regulatory systems, ensuring compliance with relevant regulations.
- Support the preparation and submission of regulatory documents, including renewals, site registrations, and minor variations.
- Regulatory Systems & Documentation
- Ensure accurate and up-to-date records of submissions and approvals in regulatory systems.
- Perform regular updates in Veeva Vault related to life cycle management activities.
- Cross-functional & Operational Support
- Coordinate sample requests through internal platforms.
- Support vendor payments and country-specific administrative tasks.
- Regulatory Intelligence & Process Improvement
- Conduct regulatory intelligence searches and maintain country-specific updates in the Country Regulatory Tool system.
- Participate in regional/global/local process improvement initiatives and support harmonization of hub procedures.
- Stakeholder Engagement & Strategic Alignment
- Align with internal stakeholders and country RA teams on submission strategies for India and APAC.
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