Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

Position Summary
This is an exciting opportunity to play a key role in supporting regulatory activities for new product registrations and lifecycle management in the Philippines. You will collaborate with global and local teams to ensure timely and compliant submissions that align with regulatory requirements. We are looking for a detail-oriented and proactive individual who is passionate about making a meaningful impact on global healthcare. Join us to grow your career while contributing to GSK's mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Prepare and submit regulatory dossiers for new product registrations and lifecycle management in compliance with local regulations.
- Collaborate with cross-functional teams to ensure high-quality submissions and timely approvals.
- Monitor and interpret regulatory changes, providing guidance on their impact to submission strategies.
- Maintain accurate records and ensure adherence to internal procedures and regulatory requirements.
- Build strong relationships with internal and external stakeholders to facilitate effective communication and collaboration.
- Identify opportunities for process improvements and contribute to enhancing regulatory systems and practices.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum 3 years of experience in regulatory affairs or a related field within the pharmaceutical industry.
- Strong understanding of regulatory processes and submission requirements in the Philippines.
- Excellent written and verbal communication skills in English.
- Detail-oriented with strong organizational and time management skills.
- Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualification
If you have the following characteristics, it would be a plus:
- Master's degree in a relevant field.
- Experience with electronic Common Technical Document (eCTD) submissions.
- Familiarity with global regulatory requirements for product lifecycle management.
- Proven ability to adapt to changing priorities and provide innovative solutions.
- Experience with digital tools and platforms used in regulatory submissions.
- Strong interpersonal skills and ability to build effective working relationships across teams.

Work Arrangement
This role is based in the Philippines and follows a hybrid working model, combining remote and on-site work.

We encourage you to apply if you are ready to take the next step in your regulatory career and contribute to advancing healthcare globally.

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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