SAP DMS
Pooja Kandpile
Executive Regulatory Affairs
Navi Mumbai
Summary
Proficient in current market regulations, standards and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
6
6
years of professional experience
9
9
years of post-secondary education
3
3
Languages
Work History
Executive Regulatory Affairs
Bharat Serums and Vaccines Limited
Airoli
10.2022 - 09.2023
- Prepared and submitted regulatory file applications and supporting documentation.
- Experience in Drug product registration, variations for Emerging markets.
- Experience in Dossier preparation as per CTD/ACTD/Country specific format.
- Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.
- Maintaining status and record of dossiers, samples and legal documents.
- Get feedback from all countries for respective variation and their timely submissions.
- Responding to clients and assisted in resolving queries for registration of the product.
- Maintaining registration status and renewal of products.
Regulatory Affairs Officer
Brooks Laboratories Ltd.
Andheri
04.2022 - 10.2022
- Good Knowledge of ICH Guidelines.
- Responsible for Preparation, Compilation & Review of CTD & ACTD Dossiers.
- Well versed with Regulatory Guidelines of Southeast Asia, Africa, Middle East, LATAM, CIS Countries.
- Co-ordination with Plant, R & D, QA and QC departments for preparation of documents.
- Responding to the Queries raised by MOH of various countries in the stipulated time frame.
- Ensure that all product artwork is updated when necessary and submitted in correct format for registration.
- Provided responses to regulatory agencies regarding product information or issues.
Regulatory Affairs Officer
Kilitch Drugs (India) Ltd
Turbhe
10.2020 - 04.2022
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Responsible for Preparation, Compilation & Review of CTD & ACTD Dossiers.
- Well versed with Regulatory Guidelines of Southeast Asia, Africa, Middle East, LATAM, CIS Countries.
- Co-ordination with Plant, R & D, QA and QC departments for preparation of documents.
- Responding to the Queries raised by MOH of various countries in the stipulated time frame.
- Ensure that all product artwork is updated when necessary and submitted in correct format for registration.
- Prioritized project-related tasks to efficiently complete essential tasks.
Assistant Technical Writer
Apotex Research Pvt. Ltd.
Vikroli
12.2017 - 02.2020
- Proved successful working within tight deadlines and a fast-paced environment.
- Responsible for creating and/or making formatting changes and edits to draft documents based on supporting documentation from business units (ie. Technical Transfer packages, Technical Operations Reports, Validation Reports).
- Liaise with TO, TW and other internal customers to monitor efficiency and effectiveness in meeting targets.
- Performing all work in compliance with current SOPs and GMPs
- Responsible for creating MDoc’s for initiating, review and approval of Change Control Assessments as CCR Originator and CCR Owner in QMS Trackwise.
- Responsible to post approved BMR’s and BPR’s in Livelink and cancellation of documents.
- Responsible to escalate any critical issues arising from the BMR/BPR while drafting.
Education
SSC -
Kendriya Vidyalaya ONGC Panvel
Panvel 03.2008 - 06.2009
HSC - SCIENCE
Kendriya Vidyalaya ONGC Panvel
PANVEL 05.2009 - 03.2011
Bachelor of Science - Pharmacy
Bachelor of Pharmacy
Shri D.D Vispute College Of Pharmacy 05.2011 - 05.2015
Master of Science - Pharmacy
Master of Pharmacy
Vivekanand Education Society’s College Of Pharmacy 04.2015 - 05.2017
Skills
Virtify eCTD
undefinedAccomplishments
Part of organizing committee for the event “CHEMTASTIC 2016” – A state level event organized at VES College of Pharmacy, Mumbai.
Participated in Zonal Level “Young Pharmacists Innovative Project Awards/Pharma Quiz”organized at Saraswati Vidya Bhavan’s College of Pharmacy, Dombivali on 19th December 2014.
Additional Information
Seminars/Workshops
One day Seminar on “Tropical Diseases: Challenges and Advances” oganized at VES College of
Pharmacy, Mumbai on 16th January 2016.
One day Worksjop on “CATSCHOL 2016-Catalysis” organized at Institute of Chemical Technology (ICT), Mumbai on 11th February 2016.
Two days Conference on “Protein Modeling and Drug Designing” organized at Guru Nanak Khalsa College, Mumbia on 24th and 25th February 2016.
Presentations
Poster presented on “Design and Synthesis of Novel Thiadiazole and Oxadiazole agents for Shikimate Kinase Inhibition” at AVISHKAR 2016-17, University of Mumbai.
Publications
Published Research Paper on Topic “Evaluation of Anti-Microbial Activity of Asafoetida” in
International Journal of Pharmaceutical Sciences And Research (IJPSR).
Review article entitled “Targets of Mitotic Machinery: Aurora Kinase Inhibitors” in Mini Reviews in Medicinal Chemistry (MRMC) journal, Bentham publication. process).
Software
QMS TRACKWISE
LIVELINK
CONTENT SERVER
Reading, Music, Learning
Reading, Music and Learning from various subjects in my Hobbies.
Timeline
Executive Regulatory Affairs
Bharat Serums and Vaccines Limited
10.2022 - 09.2023
Regulatory Affairs Officer
Brooks Laboratories Ltd.
04.2022 - 10.2022
Regulatory Affairs Officer
Kilitch Drugs (India) Ltd
10.2020 - 04.2022
Assistant Technical Writer
Apotex Research Pvt. Ltd.
12.2017 - 02.2020
Master of Science - Pharmacy
Master of Pharmacy
04.2015 - 05.2017
Bachelor of Science - Pharmacy
Bachelor of Pharmacy
05.2011 - 05.2015
HSC - SCIENCE
Kendriya Vidyalaya ONGC Panvel
05.2009 - 03.2011
SSC -
Kendriya Vidyalaya ONGC Panvel
03.2008 - 06.2009
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