Aslesha Vuyyuru
Jersey City,NJ
Summary
Resourceful Regulatory Affairs Associate with over 9 years of extensive experience in ensuring pharmaceutical products, cosmetics, and medical devices meet regulatory regulations. Deep Knowledge of requirements and processes coupled with analytical skills to develop high-impact regulatory strategies for complex drug, biologic, and medical device development programs, Expert authority in pharmacovigilance, injectables, and healthcare products facilitates rapid response issue resolution to maintain compliance and timelines. Proficient in current pharma regulations, standards, and best practices and skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data, and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Overview
12
12
years of professional experience
Work History
Regulatory Affairs Associate
Jayeda LLC
Kuwait
11.2022 - 05.2023
- Assist in developing effective strategies for addressing MoH inquiries, leading to faster resolution times.
- Wrote standard operating procedures.
- Responsible for regulatory issues of product lines.
- I am keeping abreast of local and international guidelines.
- communicating with companies abroad through emails, phone conversations, and yearly meetings.
- Scrutinize the CTD file comprising Modules 1 to Module 5 documents (e.g. PIL, SmPC, packaging material, CPP, stability studies, etc.,)and ensure the product complies with all internal and external regulatory requirements.
- Preparing the submission of NDA files/renewal/variation applications for pharma products, Medical devices & cosmetics and ensuring that those are accurate, appropriate defendable, scientifically sound, and completed promptly.
Regulatory Affairs & Pharmacovigilance Officer
Alghanim Health Care
Kuwait
10.2016 - 05.2022
- I was responsible for regulatory activities within Alghanim Healthcare company and managed all types of submissions, and releases for many of the most reputable principal companies (Pfizer, Merck, Shire, Les Laboratories Servier, Bayer Health care & consumer care) within Alghanim Health care.
- Successfully lobby with all health authority stakeholders to support quick approvals.
- Filling all data for the company and government agencies according to specific requirements of each file.
- Update Pharmacovigilance SOP's on time
- Participate in Phrmacovigilance trainings conducted by Different Prinicipals.
- Collect, record and submit AEs from all sources to Health Authorities in compliance with local requirements.
- Screen local literatures.
- Take part in audits, inspections and CAPAS management, create or update pharmacovigilance procedures and working practices.
- Mentor and train staff (including new hires) on pharmacovigilance.
- Prepare, review and update PV System PV training, attendance sheets, PV quizzes,
- Follow up & negotiate the pricing issues with the Kuwait Ministry of Health pricing department till it is finalized.
- Coordinated cross-functional teams to address complex issues, leading to more efficient problem-solving processes.
Assistant Regulatory Officer
Integra Medical
Kuwait
01.2015 - 12.2015
- Liaise with Kuwait health authorities for submission and approvals for pharmaceutical products & Medical Devices.
- Identify potential Principals and customers like retail pharmacies, hospitals, clinics, etc., and work to build relationships with decision-makers to win new accounts.
- Serve as main point of contact for new pharmaceutical products and Medical devices and build long-term relationships by assisting their product registration in Kuwait.
Assistant Professor
Malla Reddy Institute Of Pharmaceuticals
India
06.2012 - 05.2014
- Taught a diverse student population by employing various learning styles and abilities.
- Work with a head of the department to plan and teach assigned classes to undergraduate and postgraduate students in areas like pharmaceutics /drug delivery, physical pharmacy, quality control, dosage forms, etc.
- Actively conduct high-quality original research in advanced pharmaceutical formulations, drug delivery systems, and novel technologies related to pharmaceutical manufacturing and dosage forms.
Trainee
Matrix Pharmaceuticals
India
01.2011 - 12.2011
- Supported departmental tasks to increase understanding of industry processes.
- Learn and assist in pre-formulation activities like compatibility studies, analytic techniques, and stability testing to characterize API and excipient.
- Help develop and optimize dosage formulations by preparing trial batches, determining process parameters, etc.
- Execute in-vitro dissolution tests, and evaluate resulting release profiles
- Maintained database systems to track and analyze operational data.
Education
Master of Science - Drug Regulatory Affairs
Long Island University,Brooklyn
New York, NY05.2025
Master of Science - Industrial Pharmacy
Annamalai University
India10.2011
Bachelor of Science - Pharmacy
M.G.R University
India10.2009
Skills
Regulatory Training
Oral communication
Regulatory Compliance
Project Coordination
Risk Assessment
FDA Regulations
Quality Management Systems
Cost analysis and budgeting
Additional Information
TRAINING & ACTIVITIES:
- Feb 2020 : DUPHAT International Conference in Dubai
- April 2019 : Had attended Counterfeit Conference in Dubai
- Servier :Key Pharmacovigilance principles
Date: 12.06.2019 & 20.6.2020
- Lundbeck : Introduction Training to Regulatory Affairs of partners
Date: 13 .02. 2018, 20.02.2019 & 23.02.2022
- Johnson & Johnson : Product Quality Complaint Training
Date: 16.12.2017 & 05.12.2018
- Baxter : Pharmacovigilance /Compliance Training
Date: 23.03.2017 & 27.06.2019
- Bayer : General Pharmacovigilance Training AE/PTC Reporting
Date: 13.12.2017 , 03.12.2016 &19.08.2019
- Boehringher :Boehringher Target Group Refresher
Date: 18.10.2018
- AstraZeneca : Patent Safety Training
Date: 16.10.2016
- Abbott Laboratories: Pharmacovigilance Annual Refresher
Date: 09.10.2017
Timeline
Regulatory Affairs Associate
Jayeda LLC
11.2022 - 05.2023
Regulatory Affairs & Pharmacovigilance Officer
Alghanim Health Care
10.2016 - 05.2022
Assistant Regulatory Officer
Integra Medical
01.2015 - 12.2015
Assistant Professor
Malla Reddy Institute Of Pharmaceuticals
06.2012 - 05.2014
Trainee
Matrix Pharmaceuticals
01.2011 - 12.2011
Master of Science - Drug Regulatory Affairs
Long Island University,Brooklyn
Master of Science - Industrial Pharmacy
Annamalai University
Bachelor of Science - Pharmacy
M.G.R University
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