Strategy Lead, CMC Mature, Regulatory Affairs

GSK•Rockville, MD

1d•$113,850 - $189,750•Hybrid

About The Position

This role will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature projects for vaccines. The individual will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as the role involves working closely with cross-functional teams to ensure compliance and drive innovation. The position is for 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.

Requirements

Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field (advanced degree preferred).
2+ years of experience in CMC regulatory affairs, with a focus on IND and BLA submissions to the FDA.
Experience as a liaison 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.

Nice To Haves

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.

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.