Strategy Lead, CMC Mature, Regulatory Affairs
GSK
Rockville, Maryland
Full-Time
$113,850
HybridManager
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.
Find out more:
Our approach to R&D
Position Summary
You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects for vaccines. You will manage CMC regulatory activities mainly in the U.S. 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 offers visible influence on product life cycles, opportunities for 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:
Develop and implement CMC regulatory strategies mainly in the U.S. for vaccines, ensuring compliance with FDA expectations and global standards.
Prepare and review technical regulatory documents to submit to regulatory authorities mainly for the U.S., 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 mainly in the U.S. 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 Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals
Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field (advanced degree preferred).
2+ years of experience in CMC regulatory affairs, mainly in the U.S., with a focus on IND and BLA submissions to the FDA.
Experience as a liaison in the U.S. for FDA communications.
CMC experience for biologics, including regulatory requirements and technical content for submissions.
Comprehensive understanding FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics.
Experience global CMC regulatory requirements and drug development processes.
Experience with reviewing and preparing CMC submission components, particularly eCTD Module 3
Experience with manufacturing processes for biologics, including formulation, quality control, and analytical methods.
Experience translating technical and scientific information into clear, concise regulatory submissions.
Experience with mature product lifecycle management and post-approval changes.
Preferred Qualification
If you have the following characteristics, it would be a plus.
Master’s degree or PhD in a relevant scientific discipline.
Regulatory Affairs Certification (e.g., RAPS).
Experience leading teams and managing complex regulatory submissions.
Track record of effective negotiation with regulatory agencies.
Strong organizational skills to manage multiple CMC submissions and meet strict deadlines.
Proven ability to manage multiple projects while maintaining compliance with regulatory requirements.
Strong attention to detail to ensure accuracy and completeness of CMC documentation.
Ability to identify and resolve gaps or inconsistencies in regulatory submissions proactively.
Proven ability to collaborate with cross-functional teams including quality, manufacturing and clinical development.
Strong written and verbal communication skills.
Working model
This role is hybrid. You will be expected to be on-site regularly and collaborate with colleagues across sites and regions.
#GSK-LI
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 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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