Ashu Jawla
B-302, Radhey Skyline, Sanand, Ahmedabad
Summary
Accomplished executive with more than three years of experience in regulatory affairs. Expertise includes regulatory filings, compliance, NDA/ANDA submissions, and deficiency responses. Proven track record in enhancing processes and consistently meeting deadlines, contributing to organizational efficiency. Aspiring to leverage regulatory expertise to foster company growth while pursuing personal professional development.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Executive (US - Market)
Amneal Pharmaceuticals Private Limited
Ahmedabad
10.2021 - Current
1. 505(b)(2) NDA Labeling.
- Compilation and initial review of the White Paper Template (Labeling Part) for all projects.
- Compilation and initial review of the NDA Package Insert and Labels.
- Compilation and initial review of NDA Module-1 (Labeling Part) for final submission.
- Responding to any type of Query received from USFDA during the review cycle.
2. ANDA Labeling/Complex Generics.
- Coordinate with respective cross-functional teams to get documents promptly for labeling compilation.
- Compilation and initial review of Package Insert and Labels according to the latest FDA guidelines for Infusion Bags, Injectables, Ophthalmics, and OSD products.
- Compilation and initial review of Module-1 (Labeling Part) for final submission.
- Perform ESG submission and maintain the acknowledgments.
3. Labeling Deficiencies.
- Coordinate with respective cross-functional teams to collect required documents for deficiency response.
- Successfully responded all USFDA NDA and ANDA Queries (CR/DRL/IR and email correspondence) within the allotted deadlines.
- Prepared labeling response (Cover Letter and 356h Form) for both India and US site for final submission.
4. Exhibit Batches Artworks and Threshold Analysis
- Prepared the artworks of infusion bags and injectable products for stability charges.
- Reviewed the draft TA Protocol received from cross-functional teams, and provided our comments, if any.
5. Post-Approval Labeling
- Assist in the compilation of critical RLD updates and safety labeling changes.
- Checking of patent information, patent certification, and exclusivity statement of the respective product at the time of submission.
Education
Master of Pharmacy - Pharmacy
AKTU University
Lucknow, India07-2021
Post Graduate Diploma in Drug Regulatory Affairs (PGDRA) - Pharmacy
Jamia Hamdard
New Delhi, India05-2020
Bachelor of Pharmacy - Pharmacy
AKTU University
Lucknow, India06-2019
Intermediate - Science
Diwakar Model School
Sahibabad, India05-2015
High School - Science
Diwakar Model School
Sahibabad, India05-2013
Skills
- MS Word
- MS PowerPoint
- MS Excel
- NDA labeling
- ANDA labeling
- Labeling compliance
- Regulatory submission
- Cross-functional collaboration
- Labeling response
- Document review
- Time management
Accomplishments
- Employee of the Month - September 2023
- WOW Award - February 2024
Certification
- Registered pharmacist (UP Pharmacy Council of India)
Affiliations
- Participated in the International Conference on "Impact of Artificial Intelligence in Healthcare," sponsored by SERB-DST, Govt. of India, and AKTU Lucknow on February 21st-22nd, 2020
- Participated in the International e-Conference on "Empowering Healthcare & Pharma Education in 4IR Technologies," organized by the Indian Pharmaceutical Association (IPA), U.P. State Branch on June 27, 2020
- Participate in the official Guinness Book of World Records attempt 2018 - 'most people using mouthwashes simultaneously at multiple venues'
- Completed online course on "COVID-19: Operational Planning Guidelines and COVID-19 Partners Platform to support country preparedness and response" organized by World Health Organization 29th March 2020.
- Participate in the entrepreneurship awareness camp by the Department of Science and Technology, Government of India, on November 15th-17th, 2018
Languages
English
First Language
Hindi
Beginner
A1
Gujarati
Beginner
A1
Projects
DESIGN, OPTIMIZATION, AND EVALUATION OF PULSATILE RELEASE TABLET OF AMBRISENTAN
Publications
Novel Approach to Pulsatile Drug Delivery System: An Updated Review
International Journal of All Research, Education, & Scientific Methods (IJARESM), ISSN No: 2455-6211, Impact Factor: 7.429
Declaration
All what is stated in the CV are true and factual.
Ashu Jawla
Timeline
Regulatory Affairs Executive (US - Market)
Amneal Pharmaceuticals Private Limited
10.2021 - Current
Master of Pharmacy - Pharmacy
AKTU University
Post Graduate Diploma in Drug Regulatory Affairs (PGDRA) - Pharmacy
Jamia Hamdard
Bachelor of Pharmacy - Pharmacy
AKTU University
Intermediate - Science
Diwakar Model School
High School - Science
Diwakar Model School
Similar Profiles
Pratik SavaliyaPratik Savaliya
Sr. Executive at Amneal Pharmaceuticals Private LimitedSr. Executive at Amneal Pharmaceuticals Private Limited
Nitesh Kumar SenNitesh Kumar Sen
Officer-Quality Assurance (Vendor Management) at Puniska Healthcare Private Limited (Subsidiary of Amneal Pharmaceutical Private Limited)Officer-Quality Assurance (Vendor Management) at Puniska Healthcare Private Limited (Subsidiary of Amneal Pharmaceutical Private Limited)
BHAUDIPBHAI KoratBHAUDIPBHAI Korat
Production Executive at Amneal Oncology Private LimitedProduction Executive at Amneal Oncology Private Limited