Regulatory Manager, Strategy - CMC RA Small Molecules Mature Products\"

Biopharma Careers; Durham (NC); Hybrid; USD 120,000 - 150,000; Full time

Job summary

GSK seeks a Regulatory Project Manager, Strategy—CMC RA Small Molecules Mature Products—to lead CMC regulatory strategy for marketed small molecule assets. You will prepare submissions, review regulatory content, and serve as the U.S.

regulatory contact, guiding cross-functional teams through lifecycle activities and ensuring compliance across global markets. This hybrid role requires strong communication, project leadership, and a deep understanding of U.S.

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.
• 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.
• Advanced degree (Master's or PhD) in a relevant scientific field (preferred).
• Experience leading U.S. regulatory interactions and meeting preparation with the FDA.

Responsibilities

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

Skills

Communication

Digital Fluency

Influencing Without Authority

Learning Agility

Pharmaceutical Regulatory Compliance

Problem Solving

Regulatory Strategies

Strategic Leadership

Education

Bachelor's degree in pharmaceutical sciences or related

Advanced degree (Master's or PhD) preferred

Job description

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

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.

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

• 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.

Skills

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

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.