Strategic CMC Regulatory Manager, Small Molecules

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 90,000 - 140,000; Full time

Job summary

GlaxoSmithKline (GSK) invites a Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products to provide CMC regulatory support for a defined portfolio of marketed drug substances and products for global markets. This fast-paced, impactful role offers visibility across product life cycles and opportunities to influence strategies with cross-functional partners.

Based on a hybrid model in the US, candidates may be located in Durham, NC or Collegeville, PA.

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.
• 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.

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 sharebest-practices and learnings within the CMC Regulatory teamsand 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

Advanced degree (Master's or PhD)

Job description

GlaxoSmithKline (GSK) invites a Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products to provide CMC regulatory support for a defined portfolio of marketed drug substances and products for global markets. This fast-paced, impactful role offers visibility across product life cycles and opportunities to influence strategies with cross-functional partners.

Based on a hybrid model in the US, candidates may be located in Durham, NC or Collegeville, PA.