Summary
Overview
Work History
Education
Skills
Websites
Certification
Languages
Timeline
Generic
Shubham Asegaonkar

Shubham Asegaonkar

Pune

Summary

Team player experienced in directing activities of workgroups. Develops strategies, provides training, sets goals and obtains team feedback. Excellent interpersonal and communication skills. Big picture focus with excellence in communicating goals and vision to succeed. Problem solver, networker and consensus builder for techno-commercial roles with sound knowledge of Regulatory background.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Lead Associate

Genpact India Pvt Ltd
09.2022 - Current
  • Established as reliable resource for staff members troubleshooting complex submissions and training issues promptly.
  • Partnered with managers to identify and capitalize on Fist Time Right approach.
  • Experience on Singapore, U.S markets for eCTD, CTD, ACTD, NeeS & Paper submissions.
  • Volunteered to help with special projects of varying degrees of complexity.
  • Remained solutions-oriented in face of complex submissions to assist management and overall business direction.
  • Assisted clients with daily submission needs to maintain deliveries on track
  • Increased customer service success rates by quickly resolving issues.

Executive Officer

Serum Institute of India Pvt Ltd
09.2021 - 09.2022
  • Filing of MAAs related to drug approvals in APAC & other emerging markets in form of eCTD, CTD, ACTD dossiers.
  • Review & submission of CMC documents (Module 2 & 3).
  • Preparation of country specific administrative documents for Module 1.
  • Adequate Life-cycle management.
  • Participation by sharing regulatory strategy notes at all stages of development & data generation.
  • Participation & providing inputs in all calls conducted by MoH & business partners.

Associate

PAREXEL International
04.2019 - 09.2022
  • Worked varied hours to meet seasonal and business needs.
  • Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties.
  • Trained and mentored junior staff on submission strategies and techniques.
  • Pre-publishing & post publishing activates & its QC to ensure the quality of submission & documents involved.
  • Tracking of project deliverables & standardization of project related tasks.
  • Dispatch of submissions via Gateway of various health authorities.

Education

Master of Pharmacy - Industrial Pharmacy

Manipal College of Pharmaceutical Sciences
Manipal
08.2019

Bachelor of Pharmacy - Pharmaceutical Sciences

Amrutvahini College of Pharmacy
Sangamner
08.2017

Skills

  • Business Operations
  • Customer Interaction
  • Audit Preparation
  • Life-cycle management
  • Cross-functional & multi domain communication
  • Renewal filings
  • Regulatory Inputs
  • Regulatory Publishing

Certification

  • Lean Six Sigma Green Belt
  • Building Business Relationships

Languages

English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)

Timeline

Lead Associate

Genpact India Pvt Ltd
09.2022 - Current

Executive Officer

Serum Institute of India Pvt Ltd
09.2021 - 09.2022

Associate

PAREXEL International
04.2019 - 09.2022

Master of Pharmacy - Industrial Pharmacy

Manipal College of Pharmaceutical Sciences

Bachelor of Pharmacy - Pharmaceutical Sciences

Amrutvahini College of Pharmacy

Similar Profiles

CREATE PROFILE
Shubham Asegaonkar