Manager, CMC Vaccines Mature Projects, 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 peoples 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. Were uniting science technology and talent to get ahead of disease together.
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Position Summary
You will lead Chemistry Manufacturing and Controls (CMC) regulatory activities for mature vaccine projects. You will work with regulatory development quality and manufacturing colleagues to ensure compliant submissions and supply continuity. We value clear communicators who are collaborative pragmatic and focused on patient impact. This role offers visible influence on product lifecycle 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:

• Lead CMC regulatory planning and execution for mature vaccine projects and lifecycle activities.
• Prepare review and quality-check CMC content for regulatory submissions variations and maintenance filings.
• Coordinate global dossier assembly review cycles and responses to regulatory questions.
• Advise cross-functional teams on regional regulatory requirements and their impact on project timelines.
• Support supply continuity by ensuring regulatory requirements for manufacturing release and distribution are in place.
• Contribute CMC subject matter expertise and share best practices to improve regulatory processes.

• Bachelors degree in pharmacy chemistry biotechnology or related scientific discipline or equivalent experience.
• 2 years experience in CMC regulatory affairs or pharmaceutical/biopharmaceutical development with direct involvement in regulatory submissions.
• Experience preparing or contributing to lifecycle submissions and post-approval regulatory activities.
• Knowledge of CMC requirements for vaccines or biologics and of regulatory dossier formats.
• Prior experience working with cross-functional teams including quality manufacturing and clinical development.

Preferred Qualification
If you have the following characteristics it would be a plus

• Masters or PhD degree in a relevant scientific or regulatory field.
• Direct experience with vaccine development or biologics CMC regulatory strategy.
• Experience managing global submissions and interactions with major regulatory agencies.
• Experience supporting inspections and providing regulatory input for manufacturing or process changes.
• Familiarity with regulatory requirements across major regions such as the United States and European Union.
• Track record of driving process improvements or efficiencies in regulatory operations.
• Strong written and verbal communication skills with attention to detail.

#LI-GSK

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 $113850 to $189750. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the 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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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 were 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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Manager