SAURAV BODHANI
Mumbai
Summary
Detail-oriented and motivated Regulatory Associate with a solid foundation in pharmacy, clinical research, and pharmacovigilance. Experienced in supporting regulatory submissions, preparing eCTD dossiers, coordinating with crossfunctional teams, and authoring SOPs. Adept at maintaining compliance with ICH-GCP and Indian GCP guidelines. Seeking to contribute value to a forwardthinking pharmaceutical or healthcare organization.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Hospital Pharmacist
Mumbai Port Authority Hospital (Amrit HLL Pharmacy Govt of India)
Wadala Mumbai
08.2025 - Current
- Dispensed medications accurately to patients following established protocols.
- Reviewed prescriptions for appropriateness and potential drug interactions.
- Collaborated with healthcare teams to optimize patient medication therapy.
- Managed inventory of pharmaceuticals ensuring stock levels remained adequate.
Regulatory Affairs Associate
Syneos Health
Remote
09.2022 - 02.2025
- Managed regulatory submissions, objectives, events, and activities in Veeva Vault RIM system
- Supported cross-functional regulatory projects for clients including Mundipharma and AbbVie
- Prepared variation dossiers and assessed post-approval CMC changes in line with global regulatory standards
- Reviewed technical documentation from manufacturing sites, including: product specifications, labeling, batch manufacturing records, validation reports, and stability data
- Compiled initial registration dossiers (Modules 1, 2 & 3) for EU and Rest of World (ROW) markets
- Authored and supported clinical and regulatory documents with Medical Writing and Asset Writing teams.
- Developed process maps and business models to streamline workflows.
- Managed UK/US client interactions, kickoff meetings, MoM, and presentations.
- Acted as QC Manager for QC clinical documents.
- Converted ARIS process maps into BPanda process maps to standardize workflows and enhance process visualization.
- Compile, format (e.g., eCTD), and submit regulatory documents for new product approvals, variations, and renewals to agencies like the FDA and EU
- Supported timelines for submissions, trials, and approvals
- Maintained regulatory databases and electronic filing systems
- Acted as a point of contact with regulatory authorities, responding to queries and coordinating submissions
- Worked with R&D, Clinical, Medical, and Commercial teams to align regulatory strategy with product development
Hospital Pharmacist
MGM Hospital Vashi Navi Mumbai
Navi Mumbai
09.2021 - 02.2022
- Experience on handling daily OPD patients
- Experience of selling Schedule H drugs
- Management of IPD stock
- Handled OT Prescriptions
- Worked on handling MR for drug procurement
Intern Pharmacist
Wellness Forever
Parel
05.2017 - 07.2017
- Worked on handling daily customers
- Experience of Selling Schedule H drugs
- Management of Drug Store
- Worked on handling MR for drug procurement
- ICSR case processing (Pharmacovigilance Internship)
Education
Advance PGDM - Clinical Research & Pharmacovigilance
Cliniminds
Bachelor of Pharmacy -
Viva Institute of Pharmacy
VirarHSC -
S.I.W.S College
Wadala, MumbaiSSC -
S.I.W.S High School
Wadala, MumbaiDiploma in Pharmacy -
MSBTE Maharashtra
PalgharSkills
- Veeva Vault RIM
- Regulatory Standards
- Project Management
- Microsoft Office Suite
- Presentation Development
- Project Management
- Process Mapping Tools
- KMed Asset Management
- Regulatory Audits
- Clinical Documentation
- Quality Control (QC)
- Project Management
- Clinical Documentation
- Regulatory Audits
- Regulatory Submissions
Certification
- Project Management, 04/01/25
- E-QUIZ organized by Viva Institute of Pharmacy during Pharmacy Week on the occasion of World Pharmacist's Day, 09/01/20
- Participated in Webinar on 'Role of Pharmacist in Healthcare', 09/01/20
- Poster Presentation in One Day Seminar on 'Recent Advances in Capsules Technology', 09/01/20
- Poster Presentation on 'Biologics & Biosimilars', 02/01/19
- On Spot Photography Inter-Institute Cultural Youth Festival (Final Round) organized by Vidyapeeth Vidyarthi Bhavan Churchgate Mumbai, 09/01/19
- Street Play 'Antarambh' organized during Vigilance Awareness Week by Mumbai Port Trust, 01/01/18
Hobbies and Interests
- YouTuber: Travel & Lifestyle Vlogging
- Travelling
- Cooking
- Videography & Photography
Personal Information
Date of Birth: 08/28/96
Languages
English
Advanced
C1
Marathi
Proficient
C2
Hindi
Proficient
C2
Timeline
Senior Hospital Pharmacist
Mumbai Port Authority Hospital (Amrit HLL Pharmacy Govt of India)
08.2025 - Current
Regulatory Affairs Associate
Syneos Health
09.2022 - 02.2025
Hospital Pharmacist
MGM Hospital Vashi Navi Mumbai
09.2021 - 02.2022
Intern Pharmacist
Wellness Forever
05.2017 - 07.2017
Advance PGDM - Clinical Research & Pharmacovigilance
Cliniminds
Bachelor of Pharmacy -
Viva Institute of Pharmacy
HSC -
S.I.W.S College
SSC -
S.I.W.S High School
Diploma in Pharmacy -
MSBTE Maharashtra