Hybrid Strategic CMC Regulatory Manager — Small Molecules

GSK; Collegeville (PA); Hybrid; USD 100,000 - 150,000; Full time

Job summary

GSK is seeking a Regulatory Project Manager, Strategy to provide CMC regulatory support for a portfolio of small‑molecule products across global markets. The role offers exposure to lifecycle management and regulatory strategy, with visible influence on product life cycles and growth opportunities. You will lead CMC strategy, prepare regulatory submissions, and act as the U.S.

regulatory contact. This hybrid role requires on‑site collaboration, with opportunities to work across sites and

Qualifications

• Bachelor's degree in pharmacy, chemistry, pharmaceutical sciences, or related field.
• 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.

Responsibilities

• Develop CMC strategy for CMC submission documents to support small molecule marketed product lifecycle management activities in accordance with 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 sharebest‑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 pharmacy or related

Advanced degree (Master’s or PhD)

Job description

GSK is seeking a Regulatory Project Manager, Strategy to provide CMC regulatory support for a portfolio of small‑molecule products across global markets. The role offers exposure to lifecycle management and regulatory strategy, with visible influence on product life cycles and growth opportunities. You will lead CMC strategy, prepare regulatory submissions, and act as the U.S.

regulatory contact. This hybrid role requires on‑site collaboration, with opportunities to work across sites and