Regulatory Affairs Executive/Manager (2 years contract)

GlaxoSmithKline Pte Ltd; Singapore; On-site; SGD 60,000 - 85,000; Full time

Job summary

GlaxoSmithKline is seeking a Regulatory Affairs Executive/Manager to drive regulatory activities and ensure compliance for product registrations in Singapore. The role involves strategic planning of submissions, collaboration with regulatory bodies, and maintaining product lifecycle integrity, offering a chance to grow your career in an innovative biopharma environment.

Qualifications

• Knowledge of pharmaceuticals including pharmacology and quality control.
• Proven regulatory affairs experience.

Responsibilities

• Plan regulatory filings for timely product registrations.
• Liaise with regulatory authorities for license approvals.
• Manage product lifecycle maintenance.

Skills

Teamwork

Time management

Proactive improvement

Education

Bachelor’s degree in pharmacy or a science-based discipline

Job description

Site Name: Singapore - Rochester Park
Posted Date: Jul 11 2025

As a Regulatory Affairs Executive/Manager, you will play a pivotal role in supporting the business by driving regulatory activities, ensuring compliance, and enabling timely submissions and approvals for product registrations and life cycle management within the defined therapeutic areas. Your expertise will provide regulatory guidance to support product launches, promotional materials, and overall commercial strategies.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

Key Responsibilities

• Plan, strategize, and monitor regulatory filings to ensure timely submissions and approvals of new product registrations, line extensions, variation applications, and clinical trial applications.

• Liaise with local regulatory authorities and Area/Global Regulatory to deliver timely and commercially advantageous license approvals.

• Respond to regulatory questions promptly following consultation with relevant stakeholders.

• Manage product life cycle maintenance, such as changes in source, formulation, or shelf life, to ensure no impact on supply due to regulatory reasons.

• Plan and submit labelling updates in accordance with central requirements, and support pack changes and artwork development processes to ensure compliance with local registered details and corporate prescribing information, while maximizing the commercial value of the label.

• Build effective working relationships with the regulatory agency (e.g., HSA) and follow up closely on approvals for product registrations and variations.

• Collaborate with all appropriate local functions to develop and implement the best regulatory plans that support commercial goals and product launch excellence.

• Ensure compliance with local, regional, and corporate regulatory SOPs and processes. Obtain all relevant licenses and import/export permits in compliance with regulatory requirements.

• Provide regulatory input to support promotional materials and activities in accordance with local regulatory and internal requirements.

• Support QMS and quality compliance activities, including providing regulatory input to the TTS, local repacking, change control, and release of the first shipment of new products to ensure compliance with local registered details. Provide regulatory support for product incidents, recalls, and audit activities as applicable.

Why you?

Basic Qualifications:

We are looking for professionals with the following required skills to achieve our goals:

• Bachelor’s degree in pharmacy or a science-based discipline (Pharmacy preferred).

• Knowledge of pharmaceuticals, including pharmacology and technical processes such as manufacturing and quality control, gained through academic and professional experience.

• Proven regulatory affairs experience in pharmaceuticals.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Strong teamwork and interpersonal skills.

• Effective time management skills, with the ability to prioritize, multitask, and perform under pressure.

• A proactive approach to continuous improvement and innovation.

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being.
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness.

*This is a job description to aide in the job posting but does not include all job evaluation details.

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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