Jyothi Sahani
Naidupeta , Tirupati
Summary
Seeking a challenging role in a regulatory affairs department where I can utilize my expertise in regulatory submissions, compliance management, and cross-functional collaboration to contribute to the company's success. Dedicated to staying abreast of evolving regulations and leveraging my analytical skills to navigate complex regulatory landscapes effectively.
Overview
2
2
years of professional experience
Work History
Officer
Delta Biopharma Pvt. Ltd
Naidupeta , District- Tirupati
01.2023 - Current
- Prepare and submit regulatory documents such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and variations. Updated in-depth trackers of approvals and submissions.
- Ensure submissions comply with regulatory requirements and guidelines, including formatting specifications (e.g., eCTD).
- Monitor regulatory changes and updates and assess their impact on ongoing projects and submissions.
- Researched new regulatory requirements to gather information and launch resulting organizational changes.
- Addressed non-conformances and change controls to offer regulatory affairs updates to QA metrics.
- Maintain awareness of relevant regulations and guidelines issued by regulatory agencies (e.g., FDA, EMA, ICH) and implement necessary changes to ensure compliance.
Education
M. Pharmacy -
JNTU University, Anantapur
Sullurpeta ,A.P.07-2024
B. Pharma -
JNTUA University, Anantapur
Sullurpeta ,A.P.04-2021
10th -
Krishna Chaitanya
Naidupeta , A.P.03-2015
12th- BIPC -
SRI VEMA JR. COLLEGE ,
Naidupeta, A.P.Skills
- Investigation leadership
- Search and seizure
- Work Coordination
- Evidence storage
- Court appearances
- Emergency Response Coordination
Languages
Hindi
First Language
English
Advanced (C1)
C1
Telegu
Upper Intermediate (B2)
B2
Tamil
Beginner
A1
Affiliations
Research projects-
- In-silica and in-vitro evaluation of selected Siddha formulations for
anti-inflammatory and analgesic activity.
- Conducting research on regulatory requirements and guidelines and analyzing how they impact the company's products and processes.
Personal profile-
Father Name: Mr. Vinod Kumar Sahani
Date of Birth: 17/09/1999
Marital Status: Unmarried
I hereby declare that the above-written particulars are true to the best of my knowledge and belief.
Timeline
Officer
Delta Biopharma Pvt. Ltd
01.2023 - Current
M. Pharmacy -
JNTU University, Anantapur
B. Pharma -
JNTUA University, Anantapur
10th -
Krishna Chaitanya
12th- BIPC -
SRI VEMA JR. COLLEGE ,
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