Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sri Lakshmi Sai Annapurna Akella

Cambridge,MA

Summary

  • Master's degree graduate in Regulatory Affairs for Drugs, Biologic's, and Medical Devices from Northeastern University.
  • Understands all regulatory regulations and legal requirements for pharmaceuticals, biologics, and medical devices.
  • Capable of handling complicated regulatory environments, including FDA rules, EU MDR, and ISO standards. Proficient in regulatory submissions, quality assurance, and post-market surveillance.
  • Interned at top pharmaceutical firms, gaining proactive regulatory affairs experience. Industrial training exposed me to diverse pharmaceutical operations, including production, QC, QA, and warehouse management. Hospital pharmacy internship honed medication dispensing and patient care skills, emphasizing compliance and documentation. Bachelor's in Pharmacy applied theoretical knowledge to practical healthcare, showcasing attention to detail and adaptability.
  • Excellent analytical and interpersonal skills, as well as a track record of successfully interpreting and applying legislation. Keen to share knowledge to assure product safety and compliance with regulations in the pharmaceutical or medical device industries.

Overview

3
3
years of professional experience

Work History

Pharma Industrial Trainee

AUROBINDO PHARMA LTD
Hyderabad, Telangana
12.2020 - 01.2021

During my industrial training, I was exposed to a variety of divisions within pharmaceutical operations. In production, I watched manufacturing processes and actively engaged in line operations. In Quality Control (QC), I learnt about analytical testing techniques and helped with preparing the samples. Quality Assurance (QA) activities included evaluating SOPs, taking part in audits, and cooperating on process improvement projects. Warehouse operations gave information on inventory management strategies . I also obtained training in Effluent Treatment, which focused on environmental rules and treatment technology. Finally, hands-on experience with the Multi-Effective Evaporation System equipment improved my understanding of evaporation processes.

Hospital Pharmacy Intern

Narasapur Government hospital
Narsapur, Telangana
03.2018 - 05.2018

As a Hospital Pharmacy Intern, I gained valuable experience in medicine distribution, inventory management, and patient care assistance. I assisted pharmacists with a variety of activities, including medication reconciliation and sterile preparation, while maintaining regulatory compliance. I excelled at keeping thorough records and actively engaged in quality assurance projects. While pursuing my Bachelor of Pharmacy (B.Pharm.) degree, I actively applied academic knowledge to real-world healthcare scenarios. Recognized for my high attention to detail, excellent communication skills, and ability to adapt to fast-paced environments.

Education

Master of Science - Regulatory Affairs

Northeastern University
Boston, MA
12-2023

Bachelor of Science - Pharmacy

VIPER
Hyderabad,India
07-2021

Skills

  • 21 CFR Part 820 and 21 CFR PART 11
  • ISO 13485
  • ISO 14971
  • EU MDR
  • 510(K)
  • MeDRA
  • MeDWatch
  • cGMP Guidelines
  • MS Office
  • Regulatory compliance
  • Regulatory submission
  • PRE- IND meeting request
  • Quality Management System (QMS)
  • Informed consent forms
  • Labeling Requirements
  • ICH-GCP guideline/principle
  • Excellent Communication
  • Teamwork
  • Adaptability
  • Decision Making
  • Time Management
  • Writing Skills
  • Situational Analysis
  • Email Communication

Timeline

Pharma Industrial Trainee

AUROBINDO PHARMA LTD
12.2020 - 01.2021

Hospital Pharmacy Intern

Narasapur Government hospital
03.2018 - 05.2018

Master of Science - Regulatory Affairs

Northeastern University

Bachelor of Science - Pharmacy

VIPER
Sri Lakshmi Sai Annapurna Akella