Sai Jyotirmai Gorla
Hyderabad
Summary
Seasoned Regulatory Affairs Specialist with 9 year 6 months in developing effective processes and executing regulatory affairs initiatives for Solid Oral and Parenterals. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions.
Overview
9
9
years of professional experience
6
6
years of post-secondary education
Work History
Regulatory Specialist
Dr Reddy’s laboratories
Hyderabad
01.2021 - Current
- Experience in , Module 3, Dossier Writing
- Expertise in CMC modules authoring for drug products for Australia, Europe, ASEAN market
- Basic understanding on drug product regulatory requirements Understanding on ICH-Q guidelines
- Good understanding on post-approval changes and LCM submission guidelines and requirements
- Evaluated existing product dossiers of EU and US relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
- Acts as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems.
Regulatory Analyst
Dr Reddy’s laboratories
Hyderabad
07.2016 - 12.2020
- Manage regulatory submissions process, prepare high quality submission documentation to support registration activities.
- Analyze and report to management change in regulations or impending new regulations.
- Managing CMC activities for assigned products across the region.
- Prepares and submits electronic regulatory submissions according to applicable regulatory requirements and guidelines for North Africa, South Africa and ASEAN.
- Work closely with internal and external manufacturing sites to support the change control process and provide timely and accurate regulatory assessments for products in applicable region(s).
- Drafting responses to MAH for Health Authority queries.
- Preparation and review of documents required for Variation submission to Affiliates /Authorities.
Regulatory Affairs Officer
Mylan Laboratories Limited
Hyderabad
09.2015 - 07.2016
- Managed all regulatory needs for dosage form Parenteral and Solid oral dosage form for GCC and North Africa
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Preparation and review of documents required for Variation submission to Affiliates /Authorities.
- Participate as regulatory support on internal cross-functional initiatives.
Sr. Associate
Dr.Reddy's Laboratories Limited
Hyderabad
12.2012 - 08.2015
- Ensure that all data supplied to the affiliates/regulatory authorities are of the highest quality possible in terms of both content and presentation, whilst meeting agreed deadlines.
- Work proactively with members of the internal stake holders to ensure project needs / transversal activities are met compliantly within agreed timelines.
- Assist and provide support in the preparation, distribution and follow up of registration documentation required to affiliates/ regulatory authorities.
- Proper utilization of regulatory e-tools.
- Provide support transversely for submission of ASEAN and Latam
- Maintain and update all the relevant databases up-to-date.
- Review of artworks as per the labeling requirements.
Education
Master of Science - M.Pharm (Pharmaceutics)
ANNA UNIVERSITY
Tamilnadu 08.2009 - 06.2011
Bachelor of Science - Pharmacy
Pondicherry University
Pondicherry India 08.2005 - 06.2009
Skills
Doc hub
Lorenz Docubridge
RIMS
SAP Fiori
Trackwise
Ms Office
Timeline
Regulatory Specialist
Dr Reddy’s laboratories
01.2021 - Current
Regulatory Analyst
Dr Reddy’s laboratories
07.2016 - 12.2020
Regulatory Affairs Officer
Mylan Laboratories Limited
09.2015 - 07.2016
Sr. Associate
Dr.Reddy's Laboratories Limited
12.2012 - 08.2015
Master of Science - M.Pharm (Pharmaceutics)
ANNA UNIVERSITY
08.2009 - 06.2011
Bachelor of Science - Pharmacy
Pondicherry University
08.2005 - 06.2009