Priyanka Matte
@priyankamatte
Regulatory Affairs professional with M.Pharm in Pharmaceutical Quality Assurance.
IndiaWhat I'm looking for
I am a Regulatory Affairs Officer with hands-on experience preparing and submitting CTD/ACTD/eCTD dossiers (M1–M5) and managing country-specific regulatory submissions for both ROW and regulated markets. I collaborate closely with R&D, QA/QC, production, and vendors to compile dossiers, respond to regulatory queries, and support renewals and FDA document submissions.
With an M.Pharm in Pharmaceutical Quality Assurance (CGPA 8.68) and prior B.Pharm, I have practical exposure to stability summaries, TL/COPP documentation, vendor qualification, and finished-product inspections to ensure quality standards. I have also undertaken industry training and presented/published research in formulation development.
I bring strong communication, active learning, and multitasking abilities, plus proficiency with MS Office and citation software (Mendeley). I am seeking to apply my regulatory expertise to support timely approvals and maintain compliance across markets.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Officer
BDA Pharma Pvt. Ltd.
Aug 2025 - Present (4 months)
Managing preparation and submission of regulatory dossiers and documents, handling country-specific queries and coordinating with R&D, QA/QC and production for dossier data collection.
Regulatory Affairs Officer
Leben Life Sciences Pvt. Ltd.
Apr 2023 - May 2025 (2 years 1 month)
Prepared and submitted CTD/eCTD dossiers (M1–M5) for ROW and regulated markets, managed dossier renewals and country-specific query responses, and coordinated cross-functional teams to compile regulatory submissions.
Education
Degrees, certifications, and relevant coursework
Dadasaheb Balpande College of Pharmacy
Master of Pharmacy, Pharmaceutical Quality Assurance
2020 - 2022
Grade: CGPA: 8.68 (First Class with Distinction)
Activities and societies: Presented project work; attended conferences and seminars; industrial training at Scan Research Laboratories.
Completed M.Pharm in Pharmaceutical Quality Assurance with a CGPA of 8.68 (First Class with Distinction); project on formulation development and evaluation of a herbal antiinflammatory gel.
Hi-Tech College of Pharmacy, Chandrapur
Bachelor of Pharmacy, Pharmacy
2016 - 2020
Grade: CGPA: 7.58 (Distinction)
Activities and societies: Poster presentation in 2020; industrial training and participation in conferences.
Completed B.Pharm with a CGPA of 7.58 (Distinction); project on pharmacognostical and preliminary phytochemical screening of Bryophyllum pinnatum.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
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