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About the Role
This strategic leadership role defines the future direction of CMC regulatory submissions, ensuring alignment between regulatory strategy, development data strategies, and global enterprise initiatives. The role will lead CMC Regulatory Affairs engagement in key transformation programs, including Project Sonata and the implementation of ICH M4Q, while driving innovation through automation, Generative AI, structured data, and next-generation regulatory submission approaches.
Responsibilities
- Lead CMC Regulatory Affairs input into the redesign of the submissions creation process and GSK's implementation of ICH M4Q.
- Drive alignment and coordination across all CMC/NCR transformation workstreams.
- Serve as a strategic liaison between Regulatory Affairs and cross-functional partners, including Quality, Manufacturing, Technology, MSAT, and Development Sciences.
- Act as a primary point of contact for senior leaders and program stakeholders supporting Sonata and ICH M4Q initiatives.
- Influence and engage stakeholders across the organization to ensure successful program execution and adoption.
- Provide regular updates and strategic recommendations to senior governance bodies, including CMC leadership and Quality Councils.
- Identify opportunities to simplify processes and accelerate innovation through automation and emerging technologies.
- Champion regulatory transformation and continuous improvement across the organization.
Requirements
- Bachelor's Degree in Life Sciences or a related scientific discipline.
- Extensive experience in CMC regulatory submissions, dossier content generation, and process optimization within the pharmaceutical or biopharmaceutical industry.
- Strong knowledge of global regulatory requirements, quality standards, and compliance frameworks.
- Demonstrated success leading process improvement and transformational initiatives.
- Experience influencing and leading within complex global matrix organizations.
- Exceptional communication, stakeholder management, and collaboration skills.
- PhD or advanced degree in Life Sciences, Regulatory Sciences, or a related field.
- Expertise in CMC regulatory strategy and emerging regulatory submission models.
- Experience supporting large-scale digital transformation, structured content, automation, or AI-enabled regulatory initiatives.
- Proven ability to develop strategic roadmaps and influence senior leaders across multiple functions.
- Strong capability in change leadership, innovation, and enterprise-wide stakeholder engagement.
- Experience of working with regulatory filings in both vaccines and pharma products.
Skills
- Communication
- Digital Fluency
- Influencing Without Authority
- Learning Agility
- Pharmaceutical Regulatory Compliance
- Problem Solving
- Regulatory Strategies
- Strategic Leadership
Location
- Cambridge, MA
- Waltham, MA
- Rockville, MD
- San Francisco, CA
Work Type
- Hybrid
Salary/Compensations
- $212,850 to $354,750 (for specific US locations)
- $193,500 to $322,500 (for other US locations)
Benefits
- Annual bonus
- Eligibility to participate in 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
About the Company
- GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
- We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
- We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
- We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
- Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Equal Opportunity
- GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.