Regulatory Affairs Senior Specialist

On-site - Taguig 5-10 Yrs Exp Bachelor Full-time

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Job Description

The 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.

Required Technical Skills:

• 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).

Key Responsibilities:

Regulatory Submissions:

• Prepare, compile, and submit product registration dossiers, renewals, and variations in accordance with regulatory requirements.
• Liaise with regulatory authorities to foll...