Sr. Manager Regulatory Affairs (PSS06511)

About the client: PSS has been mandated to hire a Manager/ Sr. Manager - Regulatory Affairs for a leading global pharmaceutical company

Job Purpose: 

This role is for Country Regulatory Affairs for Vietnam. The main objectives are executing successful product filings, approvals, maintenance and ensuring regulatory compliance of product registrations with DAV. To develop regulatory strategies as applicable in support of new filings, pending applications and approved applications. 

Key Responsibilities:

1. To review the dossier received from the backhand RA team and give the gap analysis. Gap analysis must be provided within 3 weeks of the dossier submission in line with DAV guidelines and expectation
2. Complete responsibility for Module 1 for the new dossier Module 1 should be prepared within 1 month of receiving
3. To review the query received from DAV and send to the back hand regulatory team. Once a complete response is received, the query to be submitted to TFDA and provide acknowledgment to concerned team in India
4. Once the product is approved with DAV, need to inform the team and provide an approval package to the plant. Announcement of submission and approval must be provided to the concerned holder within 2 working days. Approval package to be provided within 5 days of approval
5. Pharmacovigilance: Need to liaise with Pharmacovigilance team in India for the approved product in Vietnam
6. Liaise with DAV for any scientific advice To get accurate information to set regulatory strategy for filing
7. Need to be well-versed with DAV variation guidelines.To categorize the variation category and need to provide gap analysis within 15 days of receiving the variation package
8. Review change control

Experience

8 -10 years of relevant experience in regulatory Affairs for Vietnam markets.

Qualification: Post Graduate Degree in Pharmaceutical Sciences/Biotechnology.

Knowledge and Skills (Functional / Technical): Strategic, Analytical, Excellent communication skills, Self-Motivated & result oriented.

Behavioral Attributes: Adaptability, Problem-Solving, Attention to detail