Utkarsh Kulshrestha
Gurugram
Summary
Results-driven professional with over 5 years of strong background in regulatory compliance, quality review, and product lifecycle management. Demonstrated ability to manage submissions and facilitate training sessions, ensuring adherence to industry standards. Conscientious, hardworking, and excels at multitasking in fast-paced environments.
Overview
7
7
years of professional experience
Work History
Artwork Specialist
Centrient Pharmaceuticals Limited
Gurugram
06.2024 - Current
- Executed product launches and managed business product artworks for B2B projects, enhancing market readiness.
- Developed artwork SOPs and prepared work instructions, facilitating timely revisions to meet project specifications.
- Facilitated artwork training sessions for relevant stakeholders.
- Coordinated with stakeholders across locations, ensuring alignment and smooth implementation of projects.
- Performed change control assessments and evaluated impacts on project outcomes.
- Conducted destruction cost analysis for running business products, identifying strategies to minimize expenses.
- Provided serialization guidance to customers and CMO based on specific requirements.
- Archived project-related documents systematically to maintain organized records. related to processes and maintained the artwork tracking system.
Senior Executive
Bal Pharma Limited
Gurugram
03.2023 - 06.2024
- Managed the life cycle of drug products for ROW markets.
- Prepared post-approval supplements and annual reports for regulatory compliance.
- Updated prescribing information and package inserts to include latest safety information.
- Initiated and reviewed drug product artworks, including labels for regulatory submissions.
- Quality review of the product development report (PDR), BMR, BPR, Biowaiver, specifications, validation, and stability documents.
- Compiled and published quality reviews for submission dispatch to relevant agencies.
- Reviewed clinical dossier (Module 5) to ensure adherence to technical rejection criteria for study data.
Senior Associate-Regulatory Affairs
APCER Lifesciences
New Delhi
06.2022 - 12.2022
- Managed product life cycle in U.S. markets, ensuring compliance and maintaining market presence.
- Executed amendments submissions (CBE-0, CBE-30, PAS) in eCTD format for U.S. regulatory compliance.
- Prepared post-approval supplements and annual reports to meet agency requirements.
- Submitted IND amendments including protocols and new investigator requests to regulatory agencies.
- Compiled and submitted annual reports (DSUR) for IND applications as per guidelines.
- Reviewed clinical data (Module 5) of ANDA submissions to confirm adherence to technical rejection criteria.
- Conducted quality reviews of Product Development Reports (PDR), BMR, BPR, MFR, biowaiver, IIG specifications validation, and stability documents to ensure regulatory alignment.
- Updated prescribing information/package inserts to reflect current safety-related information.
Research Associate
Mankind Pharma Limited
Gurugram
03.2021 - 06.2022
- Managed submissions of ANDA and amendments for US market in eCTD format.
- Handled queries from regulated markets regarding dossier labeling, formulation development, and patent amendments.
- Reviewed and prepared documents in accordance with ICH guidelines.
- Oversaw post-approval supplements and annual report preparation.
- Executed lifecycle management of products within US markets.
- Implemented pharmacopeial updates for USP and European Pharmacopoeia for API excipients and drug formulations.
- Conducted quality reviews of product development reports, including PDR, BMR, BPR, MFR, biowaiver specifications, validation, and stability documents.
- Prepared and reviewed DMFs to ensure compliance.
Senior Officer-Regulatory Affairs
Sun Pharmaceuticals Industries Limited
Vadodara
08.2019 - 02.2021
- Supported submission of NDAs, line extensions, FDCs, license renewals, and PAC applications to CDSCO according to local regulations.
- Provided scientific responses to regulatory body queries, ensuring compliance and clarity in communications.
- Reviewed technical documents including specifications, stability protocols, and process validation documents.
- Prepared and updated prescribing information to incorporate the latest safety-related data for patients and healthcare professionals.
- Initiated and reviewed drug product artworks such as cartons and labels for regulatory submission.
- Managed CDSCO online portal activities and maintained accurate internal product information database, supporting timely regulatory submissions.
- Coordinated with cross-functional departments to gather and compile essential technical documents for successful dossier filings.
- Developed regulatory strategies and implementation plans for preparation and submission of new products.
Education
Master of Science - Regulatory Affairs
National Forensic Sciences University
Gandhinagar, Gujarat07-2019
B.Pharmacy - Pharmacy
Maharishi Arvind College of Pharmacy
Jaipur, Rajasthan05-2016
Skills
- Regulatory compliance
- Quality review and assessment
- Product lifecycle management
- Change control
- Document preparation
- Cross-functional collaboration
- Technical communication
- Team collaboration
- Artwork management and training
- Problem solving
- Effective communication
Languages
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Affiliations
Attended the Global Pharma Regulatory Summit organized by CPhI from June 21, 2023, to June 23, 2023, held in Mumbai.
Timeline
Artwork Specialist
Centrient Pharmaceuticals Limited
06.2024 - Current
Senior Executive
Bal Pharma Limited
03.2023 - 06.2024
Senior Associate-Regulatory Affairs
APCER Lifesciences
06.2022 - 12.2022
Research Associate
Mankind Pharma Limited
03.2021 - 06.2022
Senior Officer-Regulatory Affairs
Sun Pharmaceuticals Industries Limited
08.2019 - 02.2021
Master of Science - Regulatory Affairs
National Forensic Sciences University
B.Pharmacy - Pharmacy
Maharishi Arvind College of Pharmacy