Sandeep Verma

Work History

Work History
Aug 2012 - Present

Regulatory Associate

Eli Lilly & Company Pvt
Since. Ltd.(Payroll-Jubilant Clinsys) Regulatory Associate Eli Lilly is highly progressive research based pharmaceutical company involved in Research, Manufacturing and marketing of branded pharmaceutical or biological formulations. Key Responsibilities Compilation and Submission of Clinical Trial Applications, Line Extension, Renewals, CMC/Safety changes applications to Regulatory Agencies of India, Sri Lanka, Nepal and Bangladesh. Liaising or negotiations with Regulatory officers for approvals. Plan, review and recommend the best regulatory strategy for submissions during the planning phase for pipeline products and support product maintenance activities of assigned portfolio based on regulatory expertise in alignment with country regulations. Represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice(as appropriate). Ensure quality oversight for Regulatory function as appropriate through developing/maintaining Regulatory Quality Plan, quality review of dossier, periodic review of archived dossier and development & maintenance of SOPs. Establish an audit plan & conduct external/self-inspections along with managing inspections from Regulatory Agencies, Corporate, and Collaboration Partners. Prepare, deliver GRP training & Provide technical support for SOPs and interpretation of Global Quality Standards & Regulations. Maintaining Regulatory Information Management systems i.e. Regulatory/competitor intelligence through closely monitor external regulatory environment and ensure timely impact assessment to provide intelligence to relevant stakeholders Proactive use of regulatory tools to communicate affiliate business partners of the global regulatory status of new products and local regulatory trends that may impact the business. Establish relationship with key regulatory officials(throughout direct interactions, industry associations, etc.) to influence regulators to foster positive regulatory environment for business and research. Provide regulatory metrics on performance that are aligned with Area & IC Regulatory Affairs criteria to measure regulatory performance to Affiliate, Area & Regional management. Projects Handled Title:“ Regulations of Biosimilars-Facts and Findings”
2000 - Present

IT Forte

IT Forte
Well-versed with MS-Office, Windows 98,, XP, Vista, Microsoft Word, and PowerPoint, Adobe Acrobat, Adobe Photo Deluxe, Microsoft excel etc. Knowledge of various scientific databases(To access and get full text research articles and E-books from various reputed databases of the world i.e. Science direct, Wiley Interscience, SpringerLink, and many more databases like this). Well aware of various submission/AE reporting tools.
May 2010 - Present

Field Sales Officer

Eli Lilly and Company Pvt
GATE Qualified held in Trainings q 6 months project internship at. Ltd. Haryana in area of regulations of drugs and biologics. q 6 months experience as a Field Sales Officer in Martin and Harris Pvt. Ltd. q
2008 - Present

Researcher

Animal
experimentation-Ethical or Not Conference Attended: Attended 60th IPC DIAMOND JUBILEE CONFERENCE, as a volunteer(LOC) member. Attended IGPA sponsored seminar on“ ADVANCES IN CLINICAL RESEARCH & DRUG DISCOVERY. Attended NATIONAL SYMPOSIUM ON TRANSLATIONAL RESEARCH IN NEW DRUG DEVEOLPMENT by UNIVERSITY OF DELHI.
Jun 2011 - Dec 2011

Eli Lilly & Company(India) Pvt

Eli Lilly & Company(India) Pvt
Year: Company:. Ltd. Scholastics q