Sridhar S

About Sridhar S

I am M Pharma graduate in Pharmaceutical Regulatory Affairs specialized, I have 6+ years experience in Regulatory Submission Management and Publishing- Managing and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle- Expert in EU-CTR Submissions via CTIS (Initial, Substantial Modification, Additional Member State, IMPD-Q)- Creating and update submission packages and Submission Content Plans for submissions to Health Authorities for development and Marketed product- Performing quality checks, validate eCTD output, and submit eCTDs through supported HA gateway- US Promotional Labeling and Advertising Materials Submissions (2253 and Non-2253 Submissions)- IND Initial, MAA Initial, Safety Reports, Briefing Book, new investigators, Amendment Submissions (protocol, IB, ICF), CSRs, DSUR submissions- NDA submissions, Renewals, Annual reports, Variations and AtO submissions to HA- Act as power-user for submission applications (Veeva Vault RIM & eCTD Manager)- Coordination of CTA/IND submissions aligning with global stake holders (RPM, GRL).

Experience

1. Global Submission Senior Specialist - Clinical Trials

   百时美施贵宝

   Oct 2023 — Present · Hyderabad, IN

Education

• T.V.M. College of Pharmacy, Bellary

  B.Pharmacy

  2013 — 2017

• JSS Academy of Higher Education & Research

  M.Pharma

  2017 — 2019

• ST. Joseph High School, Bengaluru

  6th to 10th Standard

  2006 — 2011

• Nalanda PU College, Bellary

  PUC

  2011 — 2013

• New Cambridge Primary and High School, Bengaluru

  1st to 5th Standard

  2001 — 2006