Advithi Vanya Badda
Regulatory Affairs Associate
Visakhapatnam
Summary
Self-motivated Junior Regulatory Affairs Associate holding 3 years of pharmaceutical work experience. Proven ability to effectively communicate with team members and clients. Self-directed, flexible, with strong leadership skills to consistently meet and exceed identified goals and objectives. Effective communication and organizational skills. Ability to work well with little or no supervision and can perform well under time constraints.
Overview
3
3
years of professional experience
Work History
Junior Regulatory Affairs Associate
PAREXEL International
03.2021 - Current
- Effectively handling the production of submissions and delivery of regulatory services in accordance with the defined agency guidelines
- Experience in providing electronic publishing services including document preparation (Module 1), compilation, rendering etc
- Effective interpersonal skills, strong written and oral communication, and presentation skills
- Familiar with regulatory requirements and HA guidance’s including ICH and EMA directives
- Publishing expertise in EU, UK, and Canada regulatory submissions
- Competent in handling the dispatch of finalized e-CTD submission packages to respective health authorities via CESP, MHRA, ESG portals and PSUR's via Repository
- Hands on knowledge on the payment related activities and CPP requests
- Closely worked with the Local Affiliates of EU region
- Been a part of the team which deals with the Regulatory Intelligence queries from the Authorities.
Education
Master of Science - Drug Regulatory Affairs -
Andhra University Visakhapatnam
Bachelor of Science - Pharmaceutical Sciences -
Avanti College of Pharmaceutical Sciences Visakhapatnam
08.2017
Skills
Leadership skills
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Accomplishments
- Received R&A CORE Regulatory INDIA –YOUNG ACHIEVER AWARD Q2-2022” for exceeding client expectations and supported them in achieving many milestones.
- Recognized by the management for submitting a total of 120 variations in a span of one month.
Expertise
VEEVA VAULT, EXTEDO ectd manager, Insight Publisher, Smart desk, Lorenz e-validator, Insight validator, EURS, MS office, MS Excel, PowerPoint
Timeline
Junior Regulatory Affairs Associate
PAREXEL International
03.2021 - Current
Master of Science - Drug Regulatory Affairs -
Andhra University Visakhapatnam
Bachelor of Science - Pharmaceutical Sciences -
Avanti College of Pharmaceutical Sciences Visakhapatnam
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