Regulatory Affairs Manager

GSK • New York, NY

4d • Hybrid

About The Position

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 You will lead CMC regulatory activities to support product registrations and lifecycle maintenance in the Philippines. You will work closely with colleagues across regulatory, quality, supply and project teams to prepare clear, compliant dossiers and respond to agency questions. We value people who are careful, curious and collaborative. This role offers strong growth, meaningful impact on patient access, and the chance to develop global regulatory expertise while helping GSK unite science, technology and talent to get ahead of disease together.

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Biotechnology or a related technical field.
• Minimum 3 years’ experience in regulatory affairs or the pharmaceutical industry with exposure to CMC activities.
• Practical knowledge of CTD structure and experience preparing Module 3 content.
• Strong written and spoken English, with clear document writing skills.
• Good organisation skills and ability to manage multiple tasks to strict deadlines.
• Attention to detail and a commitment to high quality work.

Nice To Haves

• Master’s degree or higher in a relevant scientific discipline.
• 3 to 5+ years’ experience with CMC submissions and post-approval variations.
• Experience with eCTD publishing tools or regulatory submission platforms.
• Knowledge of regulatory requirements in multiple international markets.
• Experience working in cross-functional, matrix teams within a global company.
• Prior experience mentoring or training junior colleagues.

Responsibilities

• Prepare CMC sections for regulatory dossiers, variations, renewals and responses to regulatory agency questions.
• Review technical data and ensure submissions are complete, accurate and ready for filing.
• Work with manufacturing, quality, supply and local regulatory teams to meet submission timelines.
• Monitor local regulatory changes and apply updates to dossiers and internal procedures.
• Identify regulatory risks, propose mitigation, and support change control and compliance activities.
• Contribute to process improvements, templates and publishing practices to increase quality and efficiency.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees