Strategic Regulatory Compliance Professional

2 weeks ago

Singapore beBeeRegulatory Full time $90,000 - $120,000
Regulatory Affairs Specialist Role
We are seeking a meticulous and proactive Regulatory Affairs Specialist to ensure compliance with global regulatory requirements and support business operations. This role involves managing licenses and registrations, advising internal stakeholders, and staying ahead of regulatory changes.

This individual will work closely with the regional regulatory team and report functionally to Senior Regulatory Affairs Specialist.

Responsibilities include:

Key Responsibilities & Duties:
1. Maintain and update a centralized regulatory database to track product licenses, renewal deadlines, and compliance documents.
2. Monitor regulatory updates from local country teams and assess their impact on business operations.
3. Implement a tracking system to ensure timely renewals, submissions, and compliance with evolving regulations.
4. Ensure proper implementation of global processes (e.g., labeling, document requests) and contribute to continuous improvement.
5. Support by working with cross-functions to respond to customer audit purposes and regulatory agency queries.
6. Oversee end-to-end product registrations, including dossier preparation, submission, and follow-up with regulatory agencies.
7. Renew licenses for existing products, ensuring adherence to labeling, MRL (Maximum Residue Limits), and safety requirements.
8. Liaise with internal teams (R&D, Quality, Legal) and external stakeholders (regulatory bodies, third-party consultants) to resolve compliance issues.
9. Prepare and submit regulatory dossiers for locally manufactured dilution products (Singapore-specific).
10. Coordinate with Singapore authorities (e.g., SFA, NEA) to secure necessary approvals.
11. Upload and maintain registration certificates, technical documents, and compliance records in the Product Lifecycle Management (PLM) system.
12. Ensure data accuracy and completeness for audit readiness and regulatory inspections.
13. Generate reports for management on registration statuses, expirations, and pending actions.
14. Maintain records of formulation changes, batch records, and compliance certifications.
15. Advise HQ, sales, and supply chain teams on regulatory considerations for new product launches, product amendments, and related information sharing. Respond to customer regulatory requests, prepare customized compliance statements for clients based on regional regulatory requirements, and hold monthly alignment calls with country regulatory teams and senior regulatory affairs executive to track registration progress and address challenges.

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