Senior Regulatory Manager

GSK

Lead Chemistry, Manufacturing and Controls regulatory activities for US and global filings in biopharma. Collaborate with cross-functional teams to support regulatory compliance and inspections.

Posted 5/23/2026full-timeUpper Providence • Pennsylvania • 🇺🇸 United StatesSenior💰 €90,000 - €150,000 per yearWebsite

About the role

Key responsibilities & impact

Lead Chemistry, Manufacturing and Controls (CMC) regulatory activities across development, registration, and early lifecycle stages.
Develop and implement CMC regulatory strategies for US and global filings and lifecycle maintenance.
Prepare, review and maintain CMC components of regulatory submissions and responses.
Provide clear regulatory advice to cross-functional teams on compliance, risk and readiness for submissions.
Lead agency interactions and act as a primary contact for regulatory authorities when required.
Support inspections, quality events and supply continuity through regulatory strategy and documentation.
Mentor colleagues and contribute to process improvements that raise quality and efficiency.

Requirements

What you’ll need

Bachelor’s degree in life sciences, pharmacy, chemistry, engineering or related field.
Minimum 6 years of CMC regulatory affairs experience in the pharmaceutical, biologics, or combination product space.
Experience preparing and authoring CMC dossier sections for US regulatory submissions.
Practical knowledge of US regulatory requirements, Good Manufacturing Practices, and relevant ICH guidance.
Proven ability to work in cross-functional teams and manage multiple projects to meet deadlines.
Strong written and verbal communication skills with experience communicating technical information clearly.

Benefits

Comp & perks

Annual bonus
Eligibility to participate in share based long term incentive program
Comprehensive benefits program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CMC regulatory activitiesregulatory strategiesregulatory submissionsCMC dossier preparationUS regulatory requirementsGood Manufacturing PracticesICH guidanceregulatory documentationquality events managementprocess improvements

Soft Skills

cross-functional teamworkproject managementcommunication skillsmentoringadvisory skillsrisk managementcompliance awarenessproblem-solvingleadershipefficiency enhancement