Director, CMC Regulatory Affairs

GSK

Director, CMC Regulatory Affairs at GSK leading regulatory strategy for global biopharmaceutical product development and approvals. Collaborating across R&D, supply and commercial to ensure compliance and efficiency.

Posted 4/17/2026full-timeWaltham • Massachusetts, Pennsylvania • 🇺🇸 United StatesLead💰 $173,250 - $288,750 per yearWebsite

About the role

Key responsibilities & impact

Lead CMC regulatory strategy for investigational and early commercial biological products across global teams.
Understand, interpret and advise on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products.
Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams.
Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place.
Identify regulatory risks and propose clear mitigation plans to senior leadership.
Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs.

Requirements

What you’ll need

Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.
Advanced degree (MSc or PhD) in a relevant scientific discipline (preferred).
Experience leading CMC regulatory teams or line management responsibility (preferred).
Experience with lifecycle management and post-approval regulatory activities (preferred).
Experience with cell and gene therapies, therapeutic proteins or other complex biologics (preferred).
Demonstrated success leading major inspections or regulatory interactions (preferred).
Practical experience with global regulatory frameworks and agency engagement (preferred).
Experience with mentoring junior colleagues (preferred).
Proven track record preparing or contributing to global CMC submissions (preferred).
Experience engaging with cross-functional teams across R&D, supply and quality (preferred).
Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities.
Ability to manage multiple projects, set priorities and meet timelines.

Benefits

Comp & perks

Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Annual bonus
Eligibility to participate in share based long term incentive program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CMC regulatory strategybiological productsregulatory requirementsclinical trialsproduct releasestabilitylifecycle managementpost-approval regulatory activitiescell and gene therapiesglobal CMC submissions

Soft Skills

mentoringleadershipcommunicationproject managementstrategic partnershiprisk identificationproblem-solvingcollaborationinterpersonal skillsorganizational skills

Certifications

MScPhD