Rohan Gavali
Senior Executive Regulatory Affairs @Euro Lifecare Ltd
Signup · Get unlimited contacts
WORK HISTORY
Senior Executive Regulatory Affairs @Euro Lifecare Ltd
Mumbai, IN
To communicate with Pharmexcil – Mumbai & Hyderabad to file documents for reimbursement of Registration Fees paid in other countries.To communicate with local FDA office (Mumbai) for License renewal.To coordinate with CRO firms for facilitating Clinical Trials, BA/BE studies.To check, compile & file dossiers in CTD, eCTD & national formats for SRA & Regulated Market & any other emerging markets.To coordinate with Suppliers/Manufacturers for Compilation and submission of queries and variations.Review and maintain database of technical documents, artworks required for Registration/ Re-registration purpose.Review of change controls.Gap analysis for new product filing.Maintaining product Life cycle.
EDUCATION
St. Wilfred Institute of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmacy
Bharati Vidyapeeth College of Pharmacy
Master's degree, Pharmacy
ABOUT ROHAN GAVALI
I am a pharmacy post-graduate with 2.1 years of hands-on experience in Regulatory Affairs, currently working as a Senior Executive at Euro Life Care Ltd. My journey in the healthcare industry has been driven by a passion for compliance, quality, and global healthcare access.In my current role, I lead and support a variety of regulatory functions across pharmaceutical markets. I am responsible for: Coordinating with Pharmexcil (Mumbai & Hyderabad) to process reimbursement applications for registration fees paid in international markets. Communicating with the local FDA (Mumbai) for license renewals and ensuring timely regulatory updates. Collaborating with CROs to manage and monitor Clinical Trials and BA/BE studies. Preparing, reviewing, and submitting dossiers in CTD, eCTD, and national formats for both Stringent Regulatory Authorities (SRA) and emerging markets. Interacting with suppliers and manufacturers to compile and address queries, variations, and documentation gaps. Conducting gap analyses for new product filings and overseeing the product life cycle from registration to re-registration. Reviewing change controls, technical documents, and artworks to ensure they meet international regulatory expectations.I’ve also worked on market expansion strategies and helped achieve product approvals across multiple countries like Brazil, Ukraine, Moldova, and Uzbekistan.My professional strengths include attention to detail, documentation precision, and cross-functional coordination. I thrive in dynamic, deadline-driven environments and am committed to ensuring regulatory compliance while supporting product accessibility worldwide.On a personal growth level, I am:Enhancing my communication and public speaking skills to work effectively with global teamsLearning Spanish to expand my international career prospectsStaying updated with evolving global regulations and ICH guidelines
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.