Director, CMC Regulatory Affairs

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.

Position Summary
You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for small molecule medicines. You will work closely with R&D, supply, quality and commercial colleagues to enable development, approval and uninterrupted supply. We value clear decision makers who build strong partnerships, solve problems with practical solutions, and support the growth of colleagues. This role offers visible impact, career growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.

Responsibilities
- Lead CMC regulatory strategy for investigational and early commercial small molecule medicines across global teams.
- Act as the CMC regulatory representative on cross-functional project and leadership teams.
- Identify regulatory risks and propose clear mitigation plans to senior leadership.
- Mentor and develop regulatory colleagues and, where required, manage a small team.

Problem solving and impact
You will direct project activities across multiple programmes and influence decisions at senior levels. You will design practical solutions for complex regulatory challenges. You will improve CMC regulatory processes and ensure regulatory positions support business needs while protecting patient supply.

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
- Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
- Extensive CMC regulatory experience, including development and manufacturing knowledge.
- Proven experience preparing or contributing to global CMC submissions.
- Strong written and verbal communication skills for internal and external stakeholders.
- Ability to manage multiple projects and meet timelines.
- Experience working with cross-functional teams (R&D, supply, quality, commercial).

Preferred Qualification
If you have the following characteristics, it would be a plus
- Advanced degree (MSc or PhD) in a relevant scientific discipline.
- Experience leading CMC regulatory teams or line management responsibility.
- Experience with lifecycle management and post-approval regulatory activities.
- Practical experience engaging with global regulatory authorities and inspections.
- Track record of mentoring and developing junior colleagues.

Location and working pattern
This role is offered as a hybrid role. You will split your time between an agreed GSK site and remote working to support team collaboration and stakeholder engagement. Specific on-site days will be agreed with your manager.
 

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.

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