Regulatory Affairs Manager

Site Name: Finance Center Building

Posted Date: Nov

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.

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Our approach to R&D Position Summary As a Regulatory Affairs Manager, you will play a vital role in ensuring compliance with local regulations while supporting the registration and lifecycle management of our products. You will collaborate with cross-functional teams to deliver regulatory strategies that align with our mission to get ahead of disease together.

This role offers an opportunity to make a meaningful impact, grow your expertise, and contribute to improving health outcomes in the Philippines. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

• Develop and implement regulatory strategies to ensure timely product approvals and compliance with local regulations.
• Prepare and submit regulatory dossiers, ensuring accuracy and alignment with requirements.
• Collaborate with internal teams to provide regulatory guidance and support for product development and lifecycle management.
• Monitor changes in regulatory requirements and communicate updates to relevant stakeholders.
• Build and maintain strong relationships with regulatory authorities to facilitate approvals and resolve issues.
• Support audits and inspections, ensuring readiness and compliance with regulatory standards.

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, or a related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry.
• Strong knowledge of local regulatory requirements and processes in the Philippines.
• Proven experience in preparing and submitting regulatory dossiers.
• Excellent communication and interpersonal skills to collaborate effectively with internal and external stakeholders.
• Strong organizational skills and attention to detail to manage multiple priorities.

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

• Advanced degree in Pharmacy, Life Sciences, or a related field.
• Experience working with regulatory authorities in the Philippines.
• Familiarity with global regulatory requirements and processes.
• Demonstrated ability to lead regulatory projects and initiatives.
• Problem-solving skills and a proactive approach to overcoming challenges.
• Passion for improving health outcomes and making a positive impact.

This is an on-site role based in the Philippines. We encourage you to apply if you are ready to take on this exciting opportunity and contribute to our mission.

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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