At a Glance
- Tasks: Lead the future of pharmaceutical regulatory submissions and drive innovation through automation and AI.
- Company: GSK, a global biopharma company with a mission to impact 2.5 billion lives by 2030.
- Benefits: Competitive salary, annual bonus, health benefits, and flexible working options.
- Other info: Join a culture that values ambition for patients and continuous improvement.
- Why this job: Be a visionary leader shaping the future of regulatory strategy in a dynamic environment.
- Qualifications: Extensive experience in CMC regulatory submissions and strong stakeholder management skills.
The predicted salary is between 63000 - 77000 £ per year.
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.
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 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.
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 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.
Senior Director, Future CMC Dossier Strategy in London employer: Gsk
GSK is an exceptional employer located in Greater London, offering a dynamic and inclusive work environment that fosters innovation and collaboration. As a Senior FinOps Product Manager, you will have the opportunity to drive impactful projects while benefiting from robust employee growth opportunities and a culture that values diverse perspectives. With a commitment to professional development and a focus on agile methodologies, GSK empowers its employees to thrive in their careers while contributing to meaningful advancements in cloud financial management.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Director, Future CMC Dossier Strategy in London
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We think you need these skills to ace Senior Director, Future CMC Dossier Strategy in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Gsk!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Gsk that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Gsk!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Gsk, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Gsk
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Gsk that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Gsk’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
