Medical Regulatory Affairs Expert
2 weeks ago
We are seeking a highly experienced Regulatory Affairs Senior Specialist to join our team at Aspen Philippines Inc.
Job SummaryThe Regulatory Affairs Senior Specialist supports the preparation and submission of regulatory documents, ensuring compliance with local and international pharmaceutical regulations.
The role involves liaising with regulatory authorities to ensure timely approvals and maintaining regulatory compliance for pharmaceutical products.
Main Responsibilities
- Prepare, compile, and submit product registration dossiers, renewals, and variations in accordance with regulatory requirements.
- Liaise with regulatory authorities to follow up on submissions and address queries or deficiencies promptly.
Requirements
- Licensed Pharmacist
- At least 7 years of experience in Regulatory Affairs including liaising with regulatory authorities.
- With understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH).
Location
Bonifacio Global City, Taguig, NCR, PH
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