Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products

GlaxoSmithKline; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

GlaxoSmithKline is seeking a Regulatory Manager, Strategy to provide CMC support for a portfolio of marketed drug substances and products. The role offers involvement in global regulatory strategies, authoring variation dossiers, and ensuring readiness for regulatory agency questions to maintain market supply.

The position collaborates with manufacturing, quality, and development teams, focusing on lifecycle management and regulatory compliance for U.S. and global markets.

Qualifications

• Bachelor’s degree or equivalent in a scientific discipline.
• 2+ years in CMC regulatory affairs focused on small molecules, lifecycle management and post-approval activities.
• Direct experience preparing or contributing to CMC sections of U.S. regulatory submissions.
• 6+ months experience with U.S. regulatory requirements and guidance related to CMC, including GMPs.

Responsibilities

• Develop CMC strategy for submission documents to support small molecule lifecycle management.
• Ensure lifecycle submissions meet regional requirements for regulatory flexibility.
• Prepare, review and quality-check CMC content for regulatory filings and post-approval variations.
• Act as primary U.S. regulatory contact for agency interactions and meeting prep.
• Advise cross-functional teams on U.S. CMC requirements and timelines to support supply continuity.
• Manage regulatory risk by identifying gaps and coordinating actions with stakeholders.
• Share CMC expertise and support process improvements across teams.

Skills

CMC Regulatory

Regulatory Strategy

Regulatory submissions

FDA interactions

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline

Advanced degree (Master’s or PhD)

Job description

Position Summary

As Regulatory Manager, Strategy you will be responsible for the provision of CMC support to a defined portfolio of marketed drug substances and products (small molecules) for global markets. This is an interesting and fast paced role which will provide opportunity for you to use and develop your CMC technical skills and regulatory knowledge for all regulatory active countries. We value people who are practical, collaborative, and focused on patient impact. This role gives visible influence on product life cycles, clear growth opportunities, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Key responsibilities

• Maintenance of the global regulatory information for assigned products by leading CMC Regulatory Matrix teams and representing CMC in the cross-functional Regulatory Matrix Teams.


• Partner with the manufacturing organisation (both Technical and Quality) to provide strategic regulatory advice for change controls, develop regulatory strategies and plans (through to implementation).


• Lead authoring of the variation dossiers and responses to Regulatory Agency questions, ensuring all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply.

Responsibilities

• Develop CMC strategy for CMC submission documents to support small molecule marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.


• Ensure information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.


• Prepare, review and quality-check CMC content for regulatory filings, post-approval variations, and maintenance submissions.


• Act as primary U.S. regulatory contact for agency interactions, written questions, and meeting preparation.


• Advise cross-functional teams on U.S. global CMC regulatory requirements and timelines to support supply continuity.


• Manage regulatory risk by identifying gaps, proposing mitigations, and coordinating actions with stakeholders.


• Ensure regulatory compliance is maintained and share best-practices and learnings within the CMC Regulatory teams and other impacted functions.


• Share CMC subject matter expertise and support continuous improvement of regulatory processes.

Basic Qualifications

• Bachelor’s degree in pharmacy, chemistry, pharmaceutical sciences, or related scientific discipline, or equivalent experience.


• Minimum of 2 years’ experience in CMC regulatory affairs focused on small molecules, including lifecycle management and post-approval activities or closely related discipline.


• Direct experience preparing or contributing to CMC sections of regulatory submissions for the U.S. market.


• Six or more months experience with U.S. regulatory requirements and guidance relevant to CMC, including Good Manufacturing Practices.

Preferred Qualifications

• Advanced degree (Master’s or PhD) in a relevant scientific field.


• Experience leading U.S. regulatory interactions and meeting preparation with the FDA.


• Demonstrated ability to work in cross-functional teams with development, manufacturing and quality colleagues.


• Strong written and verbal communication skills with attention to detail.


• Experience managing multiple product dossiers and competing priorities in a matrix environment.


• Experience supporting inspections or providing regulatory input for manufacturing changes.


• Knowledge of electronic dossier formats and submission processes.


• Proven ability to influence stakeholders and negotiate technical-regulatory resolutions.

Working Model

This role is hybrid. You will be expected to be on-site regularly and collaborate with colleagues across sites and regions.

Location

This role can be based at Durham, NC or Collegeville, PA.

#LI-GSK Skills

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership

GSK Benefits Summary

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

Accommodation

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Equal Opportunity Employer

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Culture and Ambition

We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.