Regulatory Specialist (CMC)

Roles & Responsibilities
• Prepare and technically review CMC Annual Reports for NDAs, BLAs, DMFs, Canadian Annual Notifications, and Brazil & China CMC Annual Reports
• Plan, compile, and deliver global post-approval CMC submissions across Pharma (Rx) and Vaccine (Vx) portfolios
• Collaborate with Local Operating Companies (LOCs), manufacturing sites, product owners, and global submission leads
• Ensure compliance with worldwide post-approval CMC regulatory requirements
• Monitor regulatory intelligence updates and implement relevant changes
• Manage multiple global submissions with strong accuracy and timeline adherence
• Support digital capability enhancements within regulatory operations
• Provide training and mentoring support when required

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field

Experience
• Minimum 2 years of experience in CMC Regulatory Affairs
• Experience handling NDA, BLA, DMF, and annual report submissions
• Knowledge of global post-approval CMC regulatory requirements

Skills
• Experience with CTD/eCTD documentation
• Understanding of global regulatory submission processes
• Knowledge of drug development and manufacturing lifecycle
• Strong documentation and regulatory compliance skills
• Excellent written and verbal English communication
• Strong organizational and project management abilities
• Ability to work effectively in cross-functional global teams

About the Company
GSK is a global biopharmaceutical company focused on advancing innovative medicines and vaccines, with a strong commitment to regulatory excellence, scientific innovation, and improving patient outcomes worldwide.