Swapnil Shejwal
Regulatory Affairs | Lupin Limited | US Market | ANDA | Life Cycle Management | Query Response |
- Role
- Regulatory Affairs Officer (Us-team) at Lupin
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Swapnil Shejwal
Regulatory Affairs professional with hands-on experience in managing regulatory…
Experience
Regulatory Affairs Officer (Us-team)
Jun 2023 — Present · Navi Mumbai, IN
Compilation of challenging ANDA, Amendment submissions, including NCE-1, CGT-designated applications, and complex dosage forms like oral solids, and nasal sprays Preparing and submitting responses to FDA deficiencies, including Complete Response Letters (CRLs), Information Requests (IRs), and Discipline Review Letters (DRLs) Post-approval submissions including Supplements like PAS, CBE-0, CBE-30, site transfer applications, Annual Reports, and Annual Reportable Labeling Creating, reviewing, and submitting product labeling content, including Structured Product Labeling (SPL) in compliance with FDA requirements Preparing and submitting patent amendments for patent certification, including P-I, P-II, P-IV and Section in compliance with regulatory requirements Coordinating with cross-functional teams to gather required documentation and ensure regulatory readiness.
Education
Adv.vr Manohar Institute Of Diploma In Pharmacy Nagpur Maharashtra
D.pharmacy , Pharmaceutical Sciences
Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon
B.PHARMACY , Pharmaceutical Sciences
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.