NANDINI PUNJABI
Ahmedabad
Summary
- Strategically-minded Regulatory Affairs Consultant known for high productivity and efficient task completion.
- Expertise in client communication and due diligence for timely variation package submissions.
- Possess specialized skills in regulatory strategy development, compliance management, and submission preparation.
- Excel in critical thinking, communication, and problem-solving to navigate complex regulatory environments effectively.
- Committed to ensuring successful outcomes through collaborative teamwork and innovative solutions.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Consultant-
InVentiv International Pharma Services Pvt. Ltd. (Syneos Health)
05.2022 - Current
- Authoring post-approval variations and queries for global markets using Veeva Vault software.
- Demonstrated proficiency in using Veeva Vault (RSDM/RADR), ETQ Reliance, and Liquent Reliant to author CMC content
- Executed packaging site transfer initiatives targeting diverse markets such as US, Europe, Saudi Arabia and Canada.
- Fostered effective client communication and facilitated timely submission of variation packages by diligently managing all necessary requirements.
Sr. Executive-
APCER Life Sciences Limited
01.2022 - 05.2022
- Involved in post approval activities like Annual Reports for ANDA and NDA of Mallinckrodt Pharmaceutical (MNK) and other international clients.
Regulatory Affairs-Sr. Executive-
JAMP INDIA Pharmaceutical Pvt. Limited
09.2019 - 12.2021
- Prepared ANDS submissions for Canada market as part of work profile.
- Developed expertise in ANDS compilation by working on Modules 1, 2 and 3 for solid oral dosage forms
- Reviewed technical documents, coordinated with multiple organizations to ensure compliance with Canada specific requirements, and facilitated timely generation of final submission package.
- Managed and successfully completed 10+ independent ANDS projects during my 2-year tenure at JAMP Pharma Corporation, resulting in the approval of 6 projects.
- Adept at addressing Health Canada queries like CMC clarifax, NOD, and NON to facilitate the approval process
- Reviewed US market ANDA dossiers from diverse partners and collaborated with them on coordinating bridging studies to support ANDS new submissions.
- Conducted peer-review for cross-functional team modules 1, 2, and 3 during ANDS filing.
Executive-
Torrent Pharmaceutical Limited
06.2016 - 08.2019
- Responsible for the preparation of ANDA Module 1, Module 2, and Module 3 - CMC and 3.2.R Regional information in relation to solid oral dosage forms.
- Procured and evaluated relevant documents related to CMC and administrative section in a timely manner
- Managed the submission process of Annual Reports, CBE-0, and CBE-30 filings pertaining to site shift changes and CMC changes as part of post approval tasks.
- Performed post approval labeling updation and SPL preparation
- Reviewed technical documents including product development reports, dissolution development reports, analytical validation reports, and prospective process validation protocol/reports
- Reviewed specifications and STPs for commercial products, ensuring compliance with US Pharmacopeia, BMR, BPR, Stability data, CCF, Packaging documents, and Artworks.
- Handled USFDA IR, DRL and CR queries concerning CMC-Module 3 and Module 1 section.
Education
M.Pharm - Regulatory Affairs & Quality Assurance
Institute of Pharmacy, Nirma University
01.2016
B.Pharm -
Gujarat Technical University (GTU); Kalol Institute of Pharmacy
01.2014
HSC -
Gujarat Board Asia English School
01.2010
SSC -
Gujarat Board Asia English School
01.2008
Skills
- Veeva Vault
- Power BI
- ETQ Reliance
- Liquent Reliant
- GCM trackwise
- MS Word
- MS Excel
- Adobe Professional
- SAP software
- SPL software
- ICH-Quality guidelines
- Canadian Guidelines
- USFDA Guidelines
Work Experinece
8 years
Areas Of Interest
International Regulatory Affairs (Pre-approval and Post-Approval)
Accomplishments
1. Received Appreciation note from higher authorities and Manager Recognition Badge for delivering high quality work and target achievement at Syneos Health.
2. Attained promotion to Sr. Executive in a span of two years’ experience in JAMP INDIA Pharmaceuticals Ltd.
3. Received expedited ANDS approval and provided product approval to JAMP INDIA Pharmaceuticals Ltd. within 6 months of ANDS filing.
4. Qualified GPAT exam in 2014 with AIR 668.
Certification
Published an Article in Bentham Science Publisher’s Journal named
“Applied Clinical Research, Clinical Trials and Regulatory Affairs” titled as “Comparative study of Generic Drugs registration requirements for dossier submission in African Region- Kenya, Ghana, Nigeria and Botswana”.
Languages
Hindi
First Language
English
Proficient (C2)
C2
Malayalam
Intermediate (B1)
B1
Gujarati
Proficient (C2)
C2
References
Available upon request
Disclaimer
I hereby declare that above mentioned information is true to the best of my knowledge.
Timeline
Regulatory Affairs Consultant-
InVentiv International Pharma Services Pvt. Ltd. (Syneos Health)
05.2022 - Current
Sr. Executive-
APCER Life Sciences Limited
01.2022 - 05.2022
Regulatory Affairs-Sr. Executive-
JAMP INDIA Pharmaceutical Pvt. Limited
09.2019 - 12.2021
Executive-
Torrent Pharmaceutical Limited
06.2016 - 08.2019
M.Pharm - Regulatory Affairs & Quality Assurance
Institute of Pharmacy, Nirma University
B.Pharm -
Gujarat Technical University (GTU); Kalol Institute of Pharmacy
HSC -
Gujarat Board Asia English School
SSC -
Gujarat Board Asia English School
Published an Article in Bentham Science Publisher’s Journal named
“Applied Clinical Research, Clinical Trials and Regulatory Affairs” titled as “Comparative study of Generic Drugs registration requirements for dossier submission in African Region- Kenya, Ghana, Nigeria and Botswana”.
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