Pharmaceutical Compliance Manager
1 week ago
We are looking for a highly motivated Regulatory Affairs Senior Specialist to join our team at Aspen Philippines Inc.
Job DescriptionThe 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.
The ideal candidate will have a strong understanding of regulatory requirements and guidelines (e.g., FDA, ASEAN, WHO, ICH) and at least 7 years of experience in Regulatory Affairs, including liaising with regulatory authorities.
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).
Working Conditions
Full-time
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