Gokul Bagul
Regulatory Affairs Consultant @Independent Consultant
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Affairs Consultant @Independent Consultant
London, GB
Worked with several reputed organisations such as GSK, Pfizer, AstraZeneca, UCB etc supporting critical projects aimed at delivering life-saving medicines to patients-Extensive experience in Biologics & Small molecules-Experience includes filing of initial MAAs, Emergency use authorization (EUA) for Covid alternative treatment product, post approval product life cycle maintenance, CMC variations including Site/Tech transfer projects, Brexit projects, MAH transfers, Legal entity change projects, Renewals, Line extension applications and Labeling changes-Submission in EU markets(Centralised, MRP/DCP, National procedure), MENA, LATAM/APAC & other emerging RoW markets-CMC impact regulatory assessment, Gap analysis, CMC dossier authoring and review-Preparing response to questions (RTQs) received from various regulatory authorities-Excellent CMC Project management
EDUCATION
Kingston University
MSc in Pharmaceutical Science
ABOUT GOKUL BAGUL
Around 16 years of experience & expertise in core Regulatory affairs as an independent freelance consultant-Extensive experience in Biologics & Small molecules-Experience includes filing of initial MAAs, Emergency use authorization (EUA) for Covid alternative treatment product, post approval product life cycle maintenance, CMC variations including Site/Tech transfer projects, Brexit projects, MAH transfers, Legal entity change projects, Renewals, Line extension applications and Labeling changes-Submission in EU markets(Centralised, MRP/DCP, National procedure), MENA, LATAM/APAC & other emerging RoW markets-CMC impact regulatory assessment, Gap analysis, CMC dossier authoring and review-Preparing response to questions (RTQs) received from various regulatory authorities-Excellent CMC Project management
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.