Senior Director, Future CMC Dossier Strategy

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.

We're uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

This strategic leadership role is accountable for defining the future direction of CMC regulatory submissions and 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.

The preference is for the role to be hybrid, being on-site at one of the posted locations at least two days per week.

• 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 work streams.
• 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.

• You are a visionary regulatory leader who thrives in complex environments and is passionate about transforming the future of pharmaceutical regulatory submissions.
• You bring deep expertise in CMC regulatory strategy, a strong understanding of evolving global regulatory expectations, and a proven ability to influence across large matrix organizations
• You are energized by innovation and excited by opportunities to leverage automation, structured content, and Generative AI to create more efficient and effective ways of working. Your ability to bring together diverse stakeholders, drive strategic alignment, and deliver transformational change sets you apart.
• This is a unique opportunity to help define the future of regulatory submissions at GSK while driving industry-leading innovation at the intersection of science, data, technology, and regulatory strategy.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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.

If you have the following characteristics, it would be a plus:

• 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

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership
* If you are based in Cambridge, MA;
Waltham, MA;
Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $212,850 to $354,750.
* If you are based in another US location, the annual base salary range is $193,500 to $322,500. The US salary ranges take into account a number of factors…