Strategy Lead, CMC Mature, Regulatory Affairs

About the role

At GSK, we aim to positively impact the health of 2.5 billion people by the end of the decade through the discovery and delivery of vaccines and medicines. This role involves leading CMC regulatory strategy and execution for mature projects focusing on vaccines, primarily in the U.S.

Responsibilities

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with FDA expectations and global standards.
• Prepare and review technical regulatory documents for submission 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 the primary point of contact for the FDA in the U.S., handling general inquiries, notifications, and requests for information, and leading discussions with the Agency.
• Identify and propose risk mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members to foster a culture of continuous improvement.

Qualifications

• 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.
• Experience with CMC for biologics, including regulatory requirements and technical content for submissions.
• Comprehensive understanding of FDA regulations, including 21 CFR, ICH guidelines, and GMP/GDP requirements related to biologics.
• Experience with 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 Qualifications

• 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.

Pay

The annual base salary for new hires in this position ranges from $113,850 to $189,750. 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.

Schedule

This role is hybrid. You will be expected to be on-site regularly and collaborate with colleagues across sites and regions.