Radha Krishna Reddy
Senior General Manager
Rudrapur
Summary
A seasoned Analytical Chemistry expert with 18+ years of leadership in ARD, QC, and regulatory compliance in the pharmaceutical industry. Proven track record in analytical method development, impurity profiling, dossier filing, and successful regulatory audits (USFDA, EU, WHO, etc.). Expert in building teams, systems, and strategies for compliant and efficient laboratory operations.
Overview
19
19
years of professional experience
2012
2012
years of post-secondary education
4
4
Languages
Work History
Senior General Manager – ARD & QC
Naari Pharma Pvt Ltd
08.2020 - Current
- Lead 60+ staff across ARD, QC, and Australian project management.
- Filed 13 ANDAs (8 approved), supported EU and WHO BE studies.
- Achieved zero-observation USFDA inspections.
- Led method validations, CMC documentation, and lab SOP development.
Tech Lead / Manager – ARD
Torrent Pharmaceuticals Ltd
05.2015 - 08.2020
- Managed 10 ANDA filings and 15 site transfers.
- Delivered global regulatory responses and method transfers.
Tech Lead / Manager – ARD
Syngene Intl. (Baxter Global R&D)
05.2015 - 05.2017
- Led analytical teams and introduced digital signature workflows.
- Achieved zero audit observations; validated computer systems.
Senior Manager – ARD
Shasun Pharmaceuticals Ltd
09.2010 - 04.2015
- Headed lab setup, procurement, and ANDA support for 10 products.
- Saved 6 crore via in-house BE studies.
Research Executive – ARD
Orchid Chemicals & Pharmaceuticals Ltd
11.2006 - 09.2010
- Conducted stability and degradation studies and R&D method validations.
Education
Ph.D. - Analytical Chemistry
Sri Krishnadevaraya University
M.Phil - Analytical Chemistry
Sri Krishnadevaraya University
M.Sc. - Analytical Chemistry
Sri Krishnadevaraya University
B.Sc. (M.P.C.) - undefined
Sri Venkateswara University
Skills
Analytical Method Development
Regulatory Affairs
Genotoxic Impurity Management
Nitrosamine Impurity Management
NDSRI Impurity Management
GLP
GMP
Data Integrity
21 CFR Part 11
Instrumentation
HPLC
UPLC
GC
LC-MS
UV-Vis
FTIR
PSD
XRD
Multimedia Dissolution
Accomplishments
- Zero-observation inspections by USFDA and EU regulators
- Over 35 global regulatory submissions (ANDA, EU, Australia)
- Reduced validation timelines by 30% with new SOP structure
- Implemented lab-wide digital data integrity systems
- Recognized leader and mentor for 100+ scientists
Disclaimer
I hereby declare that the above information is true to the best of my knowledge and belief. I am eager to contribute my expertise to a forward-looking organization in the pharmaceutical sector.
Personal Information
- Date of Birth: 06/14/82
- Gender: M
- Marital Status: Married
Timeline
Senior General Manager – ARD & QC
Naari Pharma Pvt Ltd
08.2020 - Current
Tech Lead / Manager – ARD
Torrent Pharmaceuticals Ltd
05.2015 - 08.2020
Tech Lead / Manager – ARD
Syngene Intl. (Baxter Global R&D)
05.2015 - 05.2017
Senior Manager – ARD
Shasun Pharmaceuticals Ltd
09.2010 - 04.2015
Research Executive – ARD
Orchid Chemicals & Pharmaceuticals Ltd
11.2006 - 09.2010
M.Phil - Analytical Chemistry
Sri Krishnadevaraya University
M.Sc. - Analytical Chemistry
Sri Krishnadevaraya University
B.Sc. (M.P.C.) - undefined
Sri Venkateswara University
Ph.D. - Analytical Chemistry
Sri Krishnadevaraya University