Director, CMC Regulatory Affairs in Ware

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.

You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products. You will work across R&D, supply, quality and commercial teams 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, professional 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 biological products across global teams.
• Understand, interpret and advise on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications.
• Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders.
• Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply.
• Identify regulatory risks and propose clear mitigation plans to senior leadership.
• Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
• Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs.
• Ensure all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.

Qualifications

Basic Qualification

• Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
• Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.

Preferred Qualification

• 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.
• Experience with cell and gene therapies, therapeutic proteins or other complex biologics.
• Demonstrated success leading major inspections or regulatory interactions.
• Practical experience with global regulatory frameworks and agency engagement.
• Experience with mentoring junior colleagues.
• Proven track record preparing or contributing to global CMC submissions.
• Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities.
• Ability to manage multiple projects, set priorities and meet timelines.

Working pattern and location

This role can be based in the United Kingdom (Ware, Stevenage or HQ), United States (UP or Waltham), Belgium (Wavre), Italy (Siena) or Switzerland (Zug). The position is offered as a hybrid role with a balance of on-site and remote working. Specific on-site days will be agreed with your manager to support team collaboration and stakeholder engagement.

How to apply

We would welcome your application. Please include a short cover letter or summary that explains how your experience fits this role and why you are interested. We are committed to inclusion and will consider reasonable adjustments to support you during the application process. Apply today and help us move science forward to make a real difference for patients.

Salary and benefits

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 $173,250 to $288,750. 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.

Why GSK?

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. 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.