CMC Mature Products Regulatory Senior Manager

Chemistry, Manufacturing, and Controls Regulatory Strategy Leader

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.

Basic Qualifications :

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 take a copy of the Job Description, as this will not be available post closure of the advert.

The US annual base salary for new hires in this position ranges from $144,375 to $240,625. 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.

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.

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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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