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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
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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 across a complex global matrix you will collaborate with teams spanning Regulatory Affairs Physical Product Development Quality Global Regulatory Operations and other key stakeholders to develop the CMC dossier of tomorrow.

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 GSKs 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:

• Bachelors 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 $212850 to $354750. If you are based in another US location the annual base salary range is $193500 to $322500. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the 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 Salary Range / Polski przedział wynagrodzenia: PLN 538500 to PLN 897500Italian Salary Range / Fascia retributiva in Italia: EUR 0 to EUR 0Belgium Salary Range / Fourchette salariale Belgique: EUR 141750 to EUR 236250The 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 candidates skills experience education level and the market rate for the 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 candidates skills experience education level and the market rate for the role. Offers are typically made within the advertised range based on the candidates 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 were 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 under federal state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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