Manager - Regulatory Affairs (PSS07834)

About the client: PSS has been mandated to hire a Manager - Regulatory Affairs for a well-known Indian pharmaceutical organisation based in Mumbai.

Job Purpose: Key Responsibilities

This role is for the country regulatory affairs for Thailand. The main objectives are executing successful product filings, approvals, maintenance, and ensuring regulatory compliance of product registrations with the Thai FDA.
To develop regulatory strategies as applicable in support of new filings, pending applications, and approved applications.
To represent the company in Thailand and establish productive relationships with the Health Authorities.
To provide support in the formulation of the Product Grid for the region & drive all regulatory processes/interfaces connected to the same.
Articulate with cross-functional teams in developing business cases for the same. Provide leadership to the Regulatory teams in the country affiliates

Qualifications & Experience.

Educational Qualifications: Post Graduate Degree in Pharmaceutical Sciences/Biotechnology.
Experience: 8 -10 years of relevant experience in Regulatory Affairs.
Knowledge and Skills (Functional / Technical): Strategic, Analytical, Excellent communication skills, Self-Motivated & result-oriented.
Behavioural Attributes: Adaptability, Problem-Solving, Attention to detail.
Location: Bangkok, Thailand
Reporting to: Lead – Regulatory Affairs, APAC & Country Manager – Central ASEAN.