PRIYANKA DHEER
Intern- Regulatory Affairs
Irvine,CA
Summary
Hardworking and passionate job seeker with strong organizational skills eager to secure an internship position. Ready to help team achieve company goals.
Overview
5
5
years of post-secondary education
3
3
Languages
Work History
Regulatory Affairs Intern
Virchow Biotech Private Limited
Hyderabad
12.2021 - 05.2022
- Researched regulatory processes of global companies to create thesis on “Regulatory Landscape of pre-filled syringes in emerging regulated markets”
- Filed for an application for a medical device product and in the process learned various required documents needed for filing 510(k) and PMA registration
- Learned the basics of ISO 13485
- Collaborated to USFDA official to troubleshoot application requirements
- Review product labeling, verify compliance with regulations, and submit to USFDA
- Organized team meetings to analyze data and facilitated discussions to identify opportunities for improvement
Laboratory Intern
Azyme Biosciences Private Limited..
Bengaluru
12.2019 - 01.2020
- Procedure followed for the purification of enzymes
- Compared laboratory data against specifications to determine if results met requirements.
- Prepared reagents and solutions, calibrating pipettes and related activities to support experiments.
- Participated in lab meetings and project presentations.
- Recorded and analyzed data to produce reports of results.
Head Coordinator
National Service Scheme
Bhubaneshwar, Odisha
07.2018 - 12.2021
- Through school-wide process based on academic achievement and leadership qualities such as public speaking
- Travel with my team to rural areas to deliver health education workshops on HIV, AIDS, sexual health, and gender issues
- Collaborate with local hospitals to ensure regular check-ups for rural residents
Education
Master of Science - Pharmaceutical Sciences
Chapman University, School of Pharmacy
Irvine, CA 08.2022 - Current
Master of Science - Biotechnology
Kalinga Institute of Industrial Technology, School of Biotechnology
India 07.2017 - 05.2022
Skills
Ability to do multi-taskingundefined
Certificate
Practical Regulatory Affairs Course
· Learn about US regulations for medical devices and the role of the FDA.
· Understand the various regulatory pathways available for medical devices in the US.
· Learn how to practically use the various FDA tools and databases to determine the required regulatory route.
Medical Device Regulations Course
· Learn about the medical device industry and how to bring new products to market 510K, PMA, de novo, ISO13485 and beyond.
Timeline
Master of Science - Pharmaceutical Sciences
Chapman University, School of Pharmacy
08.2022 - Current
Regulatory Affairs Intern
Virchow Biotech Private Limited
12.2021 - 05.2022
Laboratory Intern
Azyme Biosciences Private Limited..
12.2019 - 01.2020
Head Coordinator
National Service Scheme
07.2018 - 12.2021
Master of Science - Biotechnology
Kalinga Institute of Industrial Technology, School of Biotechnology
07.2017 - 05.2022
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