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GSK LLP · Rockville, Maryland
Regulatory Affairs Manager, CMC mRNA Vx Development Products As a Regulatory Affairs Manager in Chemistry, Manufacturing, and Controls (CMC) for mRNA-based vaccine development products, you will lead key regulatory activities that guide products from late-stage development through early lifecycle management. In close partnership and collaboration with cross-functional teams including regulatory, manufacturing, quality, and development, you will help shape regulatory CMC strategies that ensure compliance and timely approvals. We are looking for candidates who are proactive, clear communicators, and eager to grow their expertise as Regulatory CMC Managers. In this role, you will have the chance to make a meaningful impact on global health while advancing your career and aligning with GSK's mission to unite science, technology, and talent to get ahead of disease together. This is a hybrid role located in the United States in Upper Providence, PA, Rockville, MD, Waltham, MA or Durham, NC. You will be expected to work on-site regularly and collaborate with colleagues across sites and regions in the United States. If you are passionate about making a difference in global health, developing your career in regulatory science, and thriving in a collaborative environment, we want to hear from you. This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
Development and execution of CMC (Module 3/2.3) regulatory strategies for vaccine products, ensuring alignment with U.S. regulatory expectations and global requirements (mainly Europe and Japan), including health authority interactions Prepare, review, and check CMC documentation for regulatory submissions (IND/CTA, BLA/MAA/JNDA and early life cycle variations) and consultations to meet regulatory compliance and quality standards. Collaborate with and provide timely regulatory advice to cross-functional CMC workstreams and matrix teams including manufacturing and quality to support RA CMC strategy development and flawless execution Contribute to planning and tracking of CMC source documents and dossier sections to ensure Right-First-Time submission readiness. Identify regulatory risks and propose mitigation plans to ensure smooth project progress and successful submissions. Support team members, fostering continuous improvement and sharing best practices in CMC regulatory affairs.
Basic Qualifications & Skills:
A minimum of a Bachelor's degree in life sciences, pharmacy, chemistry, biotechnology, or a related scientific discipline. Minimum of 2 years of experience in CMC regulatory affairs, with exposure to vaccine or biologics development and regulatory submissions. Minimum of 1 year of experience preparing or contributing to CMC sections of regulatory submissions in the US and EU markets for biologicals and/or vaccines.
Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
Advanced degree (Master's or PhD) in a scientific or regulatory field. Knowledge of U.S. and global regulatory requirements including FDA regulations, Good Manufacturing Practices (GMP), and guideline standards (e.g. ICH) for biologicals/vaccines. Experience working collaboratively within cross-functional teams across regulatory, manufacturing, quality, and development functions. Good awareness of AI tools and eagerness to apply them responsibly to increase efficiency and/or quality of RA deliverables. Experience with the preparation of regulatory interactions and negotiations including FDA meetings (e.g. Type C or pre-BLA), CHMP Scientific advice and /or PMDA consultations. Proven ability to develop and implement CMC strategies for complex vaccine or biologics products while managing multiple priorities and deadlines in a dynamic environment. Familiarity with electronic submission formats and systems (e.g. Veeva) Experience supporting regulatory inspections and providing input on manufacturing or process changes.
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.
Details
| Company | GSK LLP |
| Location | Rockville, Maryland |
| Type | FULL TIME |
| Niche | Management Occupations |