CMC Mature Products Regulatory Senior Manager

Position Summary

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you’ll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments.

This role is based in the US at one of these locations : Rockville, MD, Upper Merion, PA or Durham, NC. 2-3 days on-site per week average presence is required.

Responsibilities

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with FDA expectations and global standards.
• Prepare and review technical regulatory documents to submit to regulatory authorities, including the FDA, to support lifecycle management of established vaccines.
• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance to ensure compliance with U.S. regulatory requirements, including Good Manufacturing Practices (GMPs).
• Serve as Point of Contact for the FDA to receive and respond to general inquiries, notifications, and requests for information, as well as to lead discussions in formal meetings and other engagements with the Agency.
• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members, fostering a culture of continuous improvement.

Why you?

Basic Qualifications :

We are looking for professionals with these required skills to achieve our goals :

Preferred Skills & Qualifications

If you have the following characteristics, it would be a plus :

Regulatory and Technical Expertise

Communication and Collaboration

Organizational and Problem-Solving Skills

Please note that this content may be used for internal purposes and will be retained as part of the job description.

The US annual base salary for new hires in this position ranges from 144,375 to 240,625 USD. This range reflects a combination of factors including location, skills, experience, and market conditions. In addition, this position offers an annual bonus and eligibility to participate in our long-term incentive program based 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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by state law, GSK may be required to capture and report expenses incurred on your behalf in the event you are afforded an interview for employment. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at openpaymentsdata.cms.gov.

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.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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.

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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses incurred on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at openpaymentsdata.cms.gov.

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