Dr. Ashwini Kulkarni
Pune
Summary
Royed Certified Regulatory Affairs Specialist with a Doctorate in Microbiology and enriched experience in navigating regulatory approval procedures. Detail-oriented, highly organized, and able to prioritize and organize projects to meet deadlines. Strong verbal, written, and interpersonal communication skills with excellent judgment and problem-solving abilities. Proactive and action-oriented with strong technological aptitude.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Assistant Professor
Modern College Of Arts Science And Commerce
07.2018 - 05.2022
- Responsible for academic, research and co and extracurricular activities and student mentoring.
- Have hands on experience of documentation, data verification and validation (DVV).
- Enriched Knowledge of global regulatory bodies, their roles and functions.
UGC NET Research Fellow
Dept of MICROBIOLOGY, Shivaji University kolhapur
07.2012 - 06.2017
- Carried out research in the field of Environmental Microbiology, Reported Lichens for their textile waste water remediation potential for the first time, Developed Lichen based bioreactor system, and Published 6 International peer reviewed research papers in renowned Journals.
- Maintained high levels of confidentiality to protect data quality and project research.
- Followed best practices and scientific protocol to reach defensible conclusions based on solid evidence.
- Authored professional scientific papers for publishing in peer-reviewed journals.
- Upheld all university and regulatory requirements for documentation of findings.
Education
Ph.D. - Microbiology
Shivaji University
Kolhapur, India02.2019
Master of Science - Microbiology
Shivaji University
Kolhapur, India06.2012
Skills
- Data Verification
- Audits
- Technical Guidance
- Impact Assessment
- Regulatory Policies
- Technical Documentation
- International Regulations
- Stakeholder Communication
- Regulatory Submissions
- Risk Management
- Policy Analysis
- Global Regulatory Compliance
Certification
1 Year Executive PG Certification in International Drug Regulatory Affairs (EPGIDRA).
Grade :- Distinction
Percentage Secured :- 94.12%
Publications
- Https://scholar.google.com/citations?view_op=view_citation&hl=en&user=O9dv7uYAAAAJ&citation_for_view=O9dv7uYAAAAJ:d1gkVwhDpl0C
- Https://scholar.google.com/citations?view_op=view_citation&hl=en&user=O9dv7uYAAAAJ&citation_for_view=O9dv7uYAAAAJ:u5HHmVD_uO8C
- Https://scholar.google.com/citations?view_op=view_citation&hl=en&user=O9dv7uYAAAAJ&citation_for_view=O9dv7uYAAAAJ:BqipwSGYUEgC
- Https://scholar.google.com/citations?view_op=view_citation&hl=en&user=O9dv7uYAAAAJ&citation_for_view=O9dv7uYAAAAJ:u-x6o8ySG0sC
- Https://scholar.google.com/citations?view_op=view_citation&hl=en&user=O9dv7uYAAAAJ&citation_for_view=O9dv7uYAAAAJ:O3NaXMp0MMsC
- Https://scholar.google.com/citations?view_op=view_citation&hl=en&user=O9dv7uYAAAAJ&citation_for_view=O9dv7uYAAAAJ:GnPB-g6toBAC
Hobbies and Interests
- Writing Poem
- Stories
- Star gazing
- Astronomy
Languages
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Bilingual or Proficient (C2)
Timeline
Assistant Professor
Modern College Of Arts Science And Commerce
07.2018 - 05.2022
UGC NET Research Fellow
Dept of MICROBIOLOGY, Shivaji University kolhapur
07.2012 - 06.2017
Ph.D. - Microbiology
Shivaji University
Master of Science - Microbiology
Shivaji University
1 Year Executive PG Certification in International Drug Regulatory Affairs (EPGIDRA).
Grade :- Distinction
Percentage Secured :- 94.12%
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