Manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products
Defines and agrees on regulatory strategy
Completes data assessment to ensure CMC dossier is authored in compliance
Identifies risks associated with submission data and information packages
Escalates issues with line manager
Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products
Identifies improvement opportunities for regulatory processes, policies, and systems
Effectively communicates in a digital context, including virtual meetings and digital platforms
Works with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide
Monitors regulatory intelligence and acts proactively on identified changes

Requirements

Min. bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields
1-2 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 when needed
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
A commitment to ongoing professional development with proven ability to learn and apply new concepts
Veeva Vault knowledge would be an asset.

Benefits

Medical Plan
Life Insurance
Employee Retirement Program
Sport and recreation cards
Recreation allowance
Annual bonus

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory strategyCMC dossier compliancepost-approval CMC regulatory proceduresICH CTD documentationregulatory processesdata assessmentrisk identificationregulatory intelligence monitoringdigital transformationanalytical thinking

Soft Skills

excellent written communicationexcellent verbal communicationteamworkleadershipinterpersonal skillscommunication skillsinfluencing skillstime managementdetail-orientedproblem-solving