Primary Job Function:

The APAC senior regulatory manager supports the APAC RA Director in the daily activities related to product registration, tracking and lifecycle maintenance.

This position ensures that product registrations across APAC countries are progressing according to timelines and supports regulatory compliance throughout the region.

A key responsibility includes monitoring and supporting execution for biosimilar registration plans, providing support and coordination to local RA teams as needed.

In addition, the position leads and executes various region-level projects and consolidations, including but not limited to:

- Label Sanity Check Project (Project “Label Guard”)

- SIR (Status Information Report) / RP (Registered Position) Improvement Project

- Generics (Gx) / Competitor Monitoring

- Other ad-hoc surveys and consolidations

Core Job Responsibilities:

1. Product registrations /Submissions

Coordinates the execution of the regulatory strategies ensuring close monitoring and follow up with the affiliates and timely reporting to the APAC RA Director.

2. Relationships & Cross Functional teamwork

Ensures good collaboration and relationships with the regulatory teams in the affiliate and the emerging markets.Supports the internal stakeholders for any regulatory affairs ad-hoc request.

3. Affiliate Coordination

Maintains effective working relationships with local RA teams.Ensures proper coordination between the RA affiliates and stakeholders in the defined areas.

4. Compliance across lifecycles

Supports the coordination of new product registration activities ensuring alignment with regulatory requirements and business timelines.Provides day‑to‑day support to ensure products remain compliant throughout their lifecycle.

5. Strategy

Assists APAC affiliates with the execution of regulatory plans that align with regional business priorities.Supports the implementation of agreed regulatory strategies and helps monitor updates to ensure continued alignment with evolving regulatory and business needs.Contributes to project teams by providing regulatory input, helping address routine issues, and supporting the Head of RA affiliates in APAC in guiding assigned activities

6. Regulatory Operations

Coordinates the preparation and submission of registration dossiers, variations, renewals, and clinical trial applications, ensuring timely execution in collaboration with APAC affiliates.Monitors timelines for key submissions (e.g., new registrations, variations, CCDS updates, PSURs, license renewals) and supports affiliates to ensure continuity of product availability.

QUALIFICATIONS

Education

Bachelor’s Degree of Pharmacy or Bachelor’s Degree of Life Science or Bachelor’s Degree of Science

Experience / Background

At least 5-7 years of working experience in similar roles (TH local and/or APAC regional roles).Understanding of regulatory affairs in pharmaceutical environment, experience interfacing with government and regulatory agencies and proven skills in developing and implementing successful regulatory strategies. Strong communication skills to effectively present regulatory information to management and government agencies

Management Skills

Uses resources effectively and efficiently.Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects.Maintain and operate within budget.Capable of analyzing and investigating issues and problem solving.

Communication Skills

Effectively practices listening skills before responding to issues.Effectively writes, presents and communicates information to internal and external clients, including divisional management.Effective negotiation skills.    

Total Quality Management (TQM) Skills

Demonstrates the ability to exercise good judgment on regulatory and compliance issues.Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities.