Business Introduction
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.
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Position Summary
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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
1. Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understands, interprets and advises 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.
2. 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.
3. Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply.
4. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
5. Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK.
6. Identify regulatory risks and propose clear mitigation plans to senior leadership.
7. Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
8. Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs.
9. Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
10. Ensures 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.
Problem Solving skills
11. Directs project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provides strategic direction, data assessment and conclusions to senior management.
12. Formulates novel approaches and influences people, systems, and processes.
13. Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies.
14. Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems.
15. Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work.
Qualifications
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
16. Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
17. Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.
Preferred Qualification
If you have the following characteristics, it would be a plus
18. Advanced degree (MSc or PhD) in a relevant scientific discipline.
19. Experience leading CMC regulatory teams or line management responsibility.
20. Experience with lifecycle management and post-approval regulatory activities.
21. Experience with cell and gene therapies, therapeutic proteins or other complex biologics.
22. Demonstrated success leading major inspections or regulatory interactions.
23. Practical experience with global regulatory frameworks and agency engagement.
24. Experience with mentoring junior colleagues
25. Proven track record preparing or contributing to global CMC submissions.
26. Experience engaging with cross-functional teams across R&D, supply and quality.
27. Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities.
28. Ability to manage multiple projects, set priorities and meet timelines.
• 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
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.