GSK · 4 hours ago
Director, CMC Regulatory Affairs
Waltham, MA
Full-time
Hybrid
Director/Executive
$173K/yr - $289K/yrGSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. The Director of CMC Regulatory Affairs will lead global regulatory strategy for complex biological products, working across various teams to enable development, approval, and supply while mentoring colleagues and managing regulatory risks.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications
Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders
Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply
May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects
Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK
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
Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability
Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines
Directs project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provides strategic direction, data assessment and conclusions to senior management
Formulates novel approaches and influences people, systems, and processes
Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies
Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems
Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work
Qualification
Required
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
Preferred
Advanced degree (MSc or PhD) in a relevant scientific discipline
Experience leading CMC regulatory teams or line management responsibility
Experience with lifecycle management and post-approval regulatory activities
Experience with cell and gene therapies, therapeutic proteins or other complex biologics
Demonstrated success leading major inspections or regulatory interactions
Practical experience with global regulatory frameworks and agency engagement
Experience with mentoring junior colleagues
Proven track record preparing or contributing to global CMC submissions
Experience engaging with cross-functional teams across R&D, supply and quality
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
Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
Founded in 1929
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
2026-01-16
2026-01-13
South China Morning Post
2026-01-08
Company data provided by crunchbase