Amulya Madasu

Recent Pharmacy graduate with a strong interest in Regulatory Affairs, including regulatory documentation, dossier preparation, compliance, and Life Cycle Management and intellectual property rights (IPR) Eager to build a career in the pharmaceutical regulatory field, with good analytical, documentation, and communication skills. Looking for an opportunity to learn, grow, and contribute to a dynamic Regulatory Affairs team.

Hands on eCTD Preparation and Submission (Intern) - PHARMA GROWTH HUB

• Trained in CTD and ECTD preparation, compilation, submission, and validation processes.
• Assist in the preparation and submission of regulatory documents to health authorities for product registration, including ANDA/MAA/ANDS/IND but not limited to these.
• Knowledge in preparation and organization of Modules 1–5 for regulatory submissions.
• Exposure to regional regulatory requirements for US, EU, UK, Japan, and Brazil markets.
• Conduct regulatory research on regulatory requirements and guidelines to generic pharmaceuticals in various market.
• Support the maintenance of regulatory files and databases, ensuring accuracy and completeness of documentation
• Assist in the review of labelling and promotional material to ensure compliance with regulatory standards.
• Any other related duties as assigned by project leader.

Bachelor of pharmacy - B. pharmacy - St. Peters institute of pharmaceutical Sciences