Independently manages multiple CMC renewals assignments
Defines and agrees on regulatory strategy
Completes data assessment for compliance with regulatory processes
Identifies risks associated with submission data
Escalates issues with line manager
Understands regulations, guidelines, procedures and policies
Identifies improvement opportunities for regulatory processes
Serves as dossier reviewer
Provides consultation and solutions as a subject matter expert
Acts as mentor/trainer for new staff
Communicates effectively in a digital context
Works with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies

Min. bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields
Min. 3 years of relevant experience in regulatory affairs, pharmaceutical industry
Familiarity with post-approval CMC regulatory procedures and ICH CTD documentation is required
Understanding of the pharmaceutical industry, drug development environment, and regulatory processes
Excellent written and verbal English language communication skills
Mindset that embraces digital transformation and innovation
Good team worker, ready to lead initiatives
Excellent interpersonal skills; communication and influencing skills
Excellent time management skills to handle multiple assignments
Detail-oriented, with emphasis on accuracy, completeness and consistency
Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes
Veeva Vault knowledge would be an asset.

Senior Regulatory Specialist, CMC Renewals

Key skills