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
2021.12 - 2022.05
- 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
2019.12 - 2020.01
- 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
2018.07 - 2021.12
- 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 2022.08 - Current
Master of Science - Biotechnology
Kalinga Institute of Industrial Technology, School of Biotechnology
India 2017.07 - 2022.05
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
2022.08 - Current
Regulatory Affairs Intern
Virchow Biotech Private Limited
2021.12 - 2022.05
Laboratory Intern
Azyme Biosciences Private Limited..
2019.12 - 2020.01
Head Coordinator
National Service Scheme
2018.07 - 2021.12
Master of Science - Biotechnology
Kalinga Institute of Industrial Technology, School of Biotechnology
2017.07 - 2022.05
Similar Profiles
Tarun DasiTarun Dasi
Biotechnology Research Associate at Virchow Biotech Private LimitedBiotechnology Research Associate at Virchow Biotech Private Limited
KRISHNA SAMPAT MULEKRISHNA SAMPAT MULE
Research Associate at Virchow Biotech Pvt.ltdResearch Associate at Virchow Biotech Pvt.ltd
Vaibhav PadaveVaibhav Padave
Sr. Marketing Executive (Tender) at Buzil Rossari Private Limited (A Subsidiary of Rossari Biotech Limited)Sr. Marketing Executive (Tender) at Buzil Rossari Private Limited (A Subsidiary of Rossari Biotech Limited)