Director, CMC Regulatory Affairs
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Massachusetts • Pennsylvania • United States
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Salary
💰 $173,250 - $288,750 per year
Job Level
About the role
- 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
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
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