Job Purpose

To support business objectives in efficient ways and in compliance with local legislation. Reporting to Head of Regulatory Manager, Regulatory Affairs Manager will play a critical role in developing and implementing plan and working procedure of the department.

Key Responsibilities:

• Planning and managing registration of assigned products

  • To ensure that all new products are registered within the timeframe upon the launching schedule of commercial.

  • To ensure that renewals of the existing products are obtained timely for the supply continuity.

  • To ensure that all technical changes are submitted and approved within in the time-frame upon the implementation.

  • To ensure that all labelling updates are submitted and approved within the Target Submission Category (TSC) and aligned with the global prescription information.

• Regulatory consultation: To provide regulatory consultation and analysis based on experience, expertise, knowledge of local regulation and regulatory environment to line manager, other functional departments, above country.

• Risk management: Periodically to identify and evaluate risks in the activities and operation of the departments and accordingly propose and take actions to mitigate impacts to the business operation and objectives.

• Process improvements: Continuously review and make the appropriate changes in order to improve the internal and cross-functional process.

• QMS compliance and GSK policies.

• Responsible to follow up at DAV for all submitted dossiers by the whole team, to ensure these dossiers are trackable and are reviewed in timely manner at DAV.

• Others: Perform other tasks relating to Regulatory activities assigned by line manager

Educational Background

Bachelor

Area of Specialisation

Pharmaceutical Science

Job-Related Experience

At least 3 years of experience in Regulatory Affairs field for multinational company, GMP registration, Price registration, import license registration and experience in following up with DAV.

*LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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