Baviya Priyadharshini Rajkumar
Summary
Dynamic Regulatory Affairs Specialist with a proven track record at Trace One India R & D Centre, showcasing expertise in Regulatory Intelligence and exceptional Team Management skills. Spearheaded comprehensive regulatory strategies, significantly enhancing compliance processes. Known for adeptly navigating complex regulatory environments and driving project success.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Research Scholar
JSS College of Pharmacy
07.2024 - Current
Working in the Department of Pharmaceutical Regulatory Affairs on the tentative thesis entitled “ Regulatory Analysis of the Life Cycle Management of the Medical Devices and In-Vitro Diagnostics ”
Regulatory Affairs Specialist & Team Lead - APAC
Trace One India R & D Centre, Chennai
07.2017 - 05.2024
- Identifying and collecting new guidelines for Foods, Cosmetics and Pet foodsreleased by the authority on a daily basis for the various countries and convert them into data for the in-house database.
- Data collection for Food additives and Impurities for Various countries.
- Ensuring all statutory and regulatory requirements in accordance with the Food Business.
- Supporting regularly to the regulatory requirements for business information.
- Checking the business systems and processes to identify any compliance issues.
- Conducts webinar and demo for the Trace One Compliance Solution.
- Query related Consultation work for Human & Pet foods and Cosmetic industries.
- Coordinating with the food Industry and the regulatory authority.
- Maintaining and Coordinating assigned Projects with the Team.
- Agreement Negotiation, Budgeting and Billing with the Clients.
- Purchase of Copyright standards from the Authority
- Writes newsletter based on the latest food news for the Trace One blog
- Train and assign the task to the junior colleagues.
Trainee-Regulatory Affairs
Apotex Research Private
08.2016 - 06.2017
- Handling of Lorenz Docubridge and Lorenz Labelbridge
- Preparation, Review and Submission of Labeling for the US and Canada Market.
- To ensure labelling artworks, proofs and SPL/PLR meet all legal and regulatory requirements.
- Preparation and review of PI's, PM's, Final printed labels/Artworks for US and Canada markets.
- Responding to labelling queries received from US-FDA and Health Canada.
- Updating PI's or PM's based on RLD/CRP updates and ensuring our PI's or PM's are in line with RLD/CRP labels.
- Work with graphic arts specialists to create artwork for printed packaging component.
- Basic knowledge for the Submission of Dossiers for the US, Canada, EU and Australia Market Basic understanding of EMEA, ASEAN, LATAM, CIS and GCC.
- Have knowledge of CTD and eCTD Dossier Preparation.
- Basic understanding of IND, NDA, ANDA filing procedures
- Have good Knowledge about Medical Devices dossier filing.
Regulatory Affairs Intern
Apotex Research Private
12.2015 - 06.2016
- Handling of Lorenz Docubridge and Lorenz Labelbridge
- Preparation, Review and Submission of Labeling for the US and Canada Market.
- To ensure labelling artworks, proofs and SPL/PLR meet all legal and regulatory requirements.
- Preparation and review of PI's, PM's, Final printed labels/Artworks for US and Canada markets.
Education
Ph.D. - Pharmaceutical Sciences
JSS Academy of Higher Education And Research
Mysore, India08-2027
PGDFSQM - Food Safety And Quality Management
Indira Gandhi Open University
New Delhi, India12-2022
Master of Pharmacy - Pharmaceutical Regulatory Affairs
JSS College of Pharmacy
Mysore, India09-2016
Bachelor of Pharmacy - Pharmacy
PSG College of Pharmacy
Coimbatore, India08-2014
Skills
- Regulatory Analysis
- Regulatory Intelligence
- Regulatory Writing
- Attention to Detail
- Team Management
- Issue resolution
- Project Management
Awards
- Mover of Mountains Trace One India Pvt. Ltd.
- Best Outgoing student PG - 2014 – 2016 Batch
- Best Outgoing student UG - 2010 – 2014 Batch
Certification
French DELF A1 & A2 from Centre international d'études pédagogiques (CIEP)
Leadership Roles
- Team Leader of Asia Pacific Team, Trace One India Pvt. Ltd.
- Student Editor of Drug Regulatory Bulletin, JSS College of Pharmacy, Ooty
- Cultural Secretary in the College Student Council, PSG College of Pharmacy
Self evaluation
- Collaboration and team work.
- Self motivation.
- Leadership.
- Problem solving.
- Time management and Flexibility.
Publications/Book Chapters
- Baviya Priyadharshini Rajkumar , Balamuralidhara V*., Mr. Arun kumar G R, Vishal Kumar Gupta, REGULATORY PERSPECTIVES OF NUTRACEUTICALS IN INDIA, Pharma Times , Vol. 56 - No. 10, October 2024
- Senthil V. L. Srianitha R. Baviyapriyadharshini, Regulatory Requirements for Drug Products Registration in South Africa, International Journal of Drug Regulatory Affairs ,Vol 3 No 4 (2015): VOLUME 3, ISSUE 4, 2015, DOI: https://doi.org/10.22270/ijdra.v3i4.171
- Ganesh GNK, Ramachandran A., Suresh V., Senthil V., Priyadharshini R. Baviya , NUTRACEUTICALS - A REGULATORY REVIEW, International Journal of Drug Regulatory Affairs : Vol 3 No 2 (2015): VOLUME 3, ISSUE 2, 2015, DOI: https://doi.org/10.22270/ijdra.v3i2.165
- V. Senthil *, R. Baviya Priyadharshini , A. Ramachandran, GNK Ganesh and Amber Shrivastava, REGULATORY PROCESS FOR IMPORT AND EXPORT OF DRUGS IN INDIA, International Journal Of Pharmaceutical Sciences And Research, DOI: 10.13040/IJPSR.0975-8232.6(12).4989-99
- Jawahar.N, Nishit Shrivastava, Ramachandran.A and Baviya Priyadharshini.R , Procedures and Applications for Marketing Authorisation of Medicinal Products in European Union, International Journal Of Pharmaceutical Sciences And Research, Jawahar.N et al /J. Pharm. Sci. & Res. Vol. 7(4), 2015, 219-225, https://www.jpsr.pharmainfo.in/Documents/Volumes/vol7Issue04/jpsr07041508.pdf
Languages
English
Bilingual or Proficient (C2)
Tamil
Bilingual or Proficient (C2)
French
Elementary (A2)
Kannada
Intermediate (B1)
Hindi
Elementary (A2)
Papers presented in the conferences
- Presented Poster: Baviya Priyadharshini R , Dr. Vishal Kumar Gupta, Dr. Balamuralidhara V "Phase IV Comparative Studies of Medical Devices in Regulated and Emerging Markets" "Beyond the Counter: Transforming Pharmacy Education for Industry and Patient Impact" APTICON 2024, Bhubaneswar (September 27 & 28, 2024)
Workshops / Symposia
- Attended 12 days workshop on “An Insight into Cyber Security and Intellectual Property Rights” conducted by AICTE Training And Learning (ATAL) Academy Faculty Development Program and JSS Science and Technology University, and JSS AHER from 2nd to 14th December 2024, Mysuru Karnataka.
- Participated 5 days Conference on " 19th International Conference on Drug Regulatory Authorities " from 14th to 18th October, 2024, New Delhi
- Attended Workshop on " Data Analysis using R and Python - An Eye Opener" (August 29 & 30, 2024)
Dissertations
- M. Pharmacy - Regulatory Requirements for the Approval of Abbreviated New Drug Submission (ANDS) in Health Canada
- B. Pharmacy - Overview on the Prospects of Newer Anti-Tubercular Drugs against Multidrug-Resistant Tuberculosis (MDR-TB)
Timeline
Research Scholar
JSS College of Pharmacy
07.2024 - Current
Regulatory Affairs Specialist & Team Lead - APAC
Trace One India R & D Centre, Chennai
07.2017 - 05.2024
Trainee-Regulatory Affairs
Apotex Research Private
08.2016 - 06.2017
Regulatory Affairs Intern
Apotex Research Private
12.2015 - 06.2016
Ph.D. - Pharmaceutical Sciences
JSS Academy of Higher Education And Research
PGDFSQM - Food Safety And Quality Management
Indira Gandhi Open University
Master of Pharmacy - Pharmaceutical Regulatory Affairs
JSS College of Pharmacy
Bachelor of Pharmacy - Pharmacy
PSG College of Pharmacy
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