G.K. SATYANARAYANA
Narayanapuram
Summary
Seeking a Challenging position in a reputed organization for the growth and advancement where I can actualize the potential, interpersonal and communication skills I have in the field of Drug Regulatory Affairs.
Overview
5
5
years of professional experience
Work History
Executive Regulatory Affairs
Pulse Pharmaceuticals Pvt.Ltd
Hyderabad
11.2021 - Current
- Compilation of regulatory submission package for ROW markets.
- Dossier compilation of Europe market, Module 2, and Module 3.
- Experience in reviewing CMC documents of solid and liquid oral dosage forms.
- Coordinated with internal teams to gather and review necessary documentation for regulatory filings, enhancing submission accuracy and efficiency.
- Preparation of New Application and submission applications to CDSCO.
Regulatory Affairs Officer -1
Lyrus Life Sciences Pvt.Ltd
Bangalore
04.2019 - 10.2021
- Review and Dossier compilation of regulatory dossiers for European markets, including preparation of Common Technical Dossiers (CTD), Module 1-5
- Compilation of regulatory submission package for ROW markets.
- Preparation and submission of post-approval variations, including regulatory amendments and updates to product dossiers.
- Knowledge about ICH guidelines.
- Collaborate with cross-functional teams, including R&D, clinical, and manufacturing, to gather necessary documentation and address regulatory issues.
- eCTD submission experience on Pharma READY submission.
- Documentation activities - bookmarking, hyper-linking, document preparation for publishing.
- Preparation and review of responses to the queries received from CDSCO.
- Preparation of New Application and submission following applications to CDSCO for Form 11, CT-16, CT-10, CT-12, CT-13, Form 29, and Form 25.
Education
M. Pharmacy (Pharmaceutics) -
University College Of Pharmaceutical Sciences, K.U, Warangal
B. Pharmacy (Pharmacy) -
Smt.Sarojini Ramulamma College of Pharmacy, P.U Mahabubnagar
Skills
- Excellent document organization and attention to detail
- Effective cross-functional communication and coordination
- Regulatory Submissions
Accomplishments
Secured 110 rank in PGECET in the year of 2015
Extracurricular Activities
Served as volunteer in Annual College day celebrations. Participated in various Quiz competitions. Actively involved in group discussions
Disclaimer
I hereby declare that the above particulars are true and correct to the best of my knowledge and belief
Personal Information
- Father's Name: G.K.Venkateshwarlu
- Date of Birth: 02/28/93
- Gender: Male
- Nationality: Hindhu
- Marital Status: Married
Hobbies and Interests
- Playing Cricket and Caroms
- Listening Music
Languages
- Telugu
- Hindi
- English
Timeline
Executive Regulatory Affairs
Pulse Pharmaceuticals Pvt.Ltd
11.2021 - Current
Regulatory Affairs Officer -1
Lyrus Life Sciences Pvt.Ltd
04.2019 - 10.2021
M. Pharmacy (Pharmaceutics) -
University College Of Pharmaceutical Sciences, K.U, Warangal
B. Pharmacy (Pharmacy) -
Smt.Sarojini Ramulamma College of Pharmacy, P.U Mahabubnagar
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