Headline

Regulatory Affairs Management Support IND

About

I am currently working as a complementary worker at GlaxoSmithKline (GSK) in the SDE Subcoordination team- Pipeline, supporting regulatory submission activities and ensuring compliance with global standards. My journey at GSK began as an intern, where I developed a strong foundation in regulatory processes, submission coordination, and cross-functional collaboration. In my current role, I focus on managing submission timelines, coordinating dossier preparation, maintaining high-quality documentation, and streamlining workflows to meet regulatory milestones efficiently. I am committed to growing my expertise in regulatory affairs and contributing to impactful healthcare solutions that improve patient access to life-saving treatments worldwide.

Location

Bengaluru

Work experience

Regulatory Affairs Management Support IND at GSK, Sep 2025 - Present · 10 mos, Karnataka, India

Regulatory Affairs Apprentice (under Future Leaders Program, 2024) at GSK, Aug 2024 - Sep 2025 · 1 yr 2 mos, Bengaluru, Karnataka, India, • Formulate global product development and regulatory strategy to leverage project timelines at GSK Global Capability Center (GCC). • Review and author specifications, technical modules, test procedures, process validation protocols, batch manufacturing records and reports for upcoming EU, U.S. Food & Drug Administration (FDA) Approvals, ROW Dossiers, In-Lincensing & Acquired Product due diligence.

Pharmaceutical Management Trainee at Micro Labs Limited, May 2024 - Jul 2024 · 3 mos, Bengaluru, Karnataka, India, • Assessed and troubleshot end-to-end ‘Supply Chain for Sterile Products’ (viz. eye drops and more from filling, manufacturing to packaging and tracking). • Facilitated inventory upkeep, sanction and management of raw materials, product packages and user manuals. • Formulated and reviewed BMR, bookkeeping and documentation. • Developed, coordinated and engaged staff for capacity building and training programmes.

Pharmaceutical Internship at Medreich Limited, Apr 2022 - Jun 2022 · 3 mos, Bengaluru, Karnataka, India, • Augmented formulation of drug production indicators in ‘Liquid and Tablet Dosage Manufacturing Sections’ to ensure precise data entry, bookkeeping and reporting (daily and monthly). • Accelerated product quality control and compliance with industrial and corporate benchmarks by 6%. • Experimental assistance in ‘Research and Development (R&D)’ to formulate sample preparations and reports in laboratory activities, scientific protocols and procedures.

Education

Bachelor of Pharmacy (B.Pharmacy) under Prof. MRD Meritorious Scholarship (2019 - 2023), PES University

Intermediate | Science | UPMSP, DBS Intercollege, Jaunpur, Uttar Pradesh