Senior Director, Future CMC Dossier Strategy

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 194,000 - 355,000; Full time

Job summary

GlaxoSmithKline seeks a strategic CMC Regulatory leader to define future regulatory submission directions and align development data strategies with global initiatives. You will drive CMC input for Sonata and ICH M4Q, coordinating across Quality, Manufacturing, Technology, MSAT, and Development Sciences to advance transformation programs.

You will partner with senior leaders, champion automation and data-driven approaches, and shape regulatory submissions across vaccines and pharma products.

Qualifications

• Bachelor's degree in life sciences or related field.
• Extensive experience in CMC regulatory submissions and content generation.
• Strong knowledge of global regulatory requirements and compliance.
• Proven success leading process improvement and transformational initiatives.
• Experience influencing in complex global matrix organizations.
• Exceptional communication and stakeholder management skills.

Responsibilities

• Lead CMC Regulatory Affairs input into submissions redesign and ICH M4Q implementation.
• Drive alignment across all CMC/NCR transformation workstreams.
• Act as strategic liaison between Regulatory Affairs and Quality, Manufacturing, Technology, MSAT and Development Sciences.
• Serve as primary contact for senior leaders and program stakeholders for Sonata and ICH M4Q.
• Influence across the organization to ensure successful program execution and adoption.
• Provide regular updates and strategic recommendations to senior governance bodies.
• Identify opportunities to simplify processes and accelerate innovation via automation and AI.
• Champion regulatory transformation and continuous improvement.

Skills

CMC Regulatory Strategy

Regulatory Submissions

Transformational Leadership

Stakeholder Engagement

Automation / AI

Communication

Education

Bachelor's Degree in Life Sciences

PhD or advanced degree (preferred)

Job description

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

Overview

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.

Working model:

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

In This Role You Will:

• 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.

Why You?

• 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.

Basic Qualifications:

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.

Preferred Qualifications:

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

Skills

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 including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Polish Salary Range / Polski przedzia wynagrodzenia: PLN 538,500 to PLN 897,500Italian Salary Range / Fascia retributiva in Italia: EUR 0 to EUR 0Belgium Salary Range / Fourchette salariale - Belgique: EUR 141,750 to EUR 236,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. 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.

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