Mahendra Reddy P
Hyderabad
Summary
Dynamic Regulatory Affairs professional with experience at Dr. Reddy's Laboratories, adept at managing complex FDA submissions and ensuring compliance with ICH guidelines. Proficient in Lorenz Docu Bridge, RIMS and SAP. Excel in cross-functional collaboration and strategic problem-solving, driving successful outcomes in regulatory processes and product launches.
Overview
11
11
years of professional experience
Work History
Team Member, Regulatory Affairs
Dr. Reddy's Laboratories
Hyderabad
01.2022 - Current
- Format, Compile, Review & Publish US FDA post approval (PAS/CBE/ Annual Reports) submission packages within agreed timeline.
- Change control management: Evaluation and classification of post approval change notifications as per the EU/US regulatory guidance.
- Supported submission of variations and renewals for EU market, ensuring compliance with regulatory requirements.
- Resolved deficiencies and ensured timely responses to regulatory agencies.
- Coordinated with CFTs to generate additional data, fulfilling filing requirements within established timelines.
- Review and approval of MPRs, Process Qualification Protocols & Reports, Specifications and Stability protocols.
- Identified discrepancies between approved dossiers and GMP documents, facilitating corrective actions for regulatory compliance.
- Oversaw regulatory document life cycle management for effective compliance.
- Developed regulatory strategies for CFTs regarding proposed changes in manufacturing processes, specifications, STPs, stability, API changes, and vendor changes.
- Interface with the US FDA for CMC submissions and CMC-related issues.
Quality Specialist - Regulatory support
Granules India Ltd
Hyderabad
01.2019 - 01.2022
- Coordinated regulatory operations through preparation and management of critical regulatory documents, ensuring compliance with industry standards.
- Ensured compliance through thorough review and preparation of Master BMRs and BPRs.
- Evaluated product quality through preparation of APQRs and compliance metrics analysis.
- Coordinated with CFTs to generate additional data and meet regulatory filing requirements.
- Oversaw management of critical documentation, including issuance and tracking procedures.
- Reviewed unplanned deviations and change controls, identifying opportunities for continuous improvement initiatives.
- Contributed to investigations of market complaints, improving communication of outcomes to stakeholders.
Quality Specialist - Regulatory support
MSN Laboratories Pvt limited
Hyderabad
01.2015 - 01.2019
- Managed critical regulatory documents to ensure compliance with industry standards.
- Collaborated with cross-functional teams to generate data meeting regulatory filing requirements.
- Reviewed and prepared Master Batch Manufacturing Records and Batch Packaging Records.
- Tracked and organized essential documentation to maintain regulatory compliance and facilitate audits.
- Executed process validations to ensure manufacturing consistency.
- Compiled Annual Product Quality Reviews to support continuous improvement in quality assurance.
- Investigated and documented market complaints for comprehensive resolution.
- Conducted line clearance activities during manufacturing and packing stages.
Education
M Pharm - Raichur
N. E. T. Pharmacy College
Raichur01.2015
B Pharm - Bangalore
N. E. T. Pharmacy College
Bangalore01.2013
Intermediate - Ongole
Sri Pratibha Junior College
Ongole01.2009
Matriculation -
Neredupalli High school
01.2007
Skills
- Regulatory filing
- ICH Guidelines
- SUPAC Guidelines
- NDA/ANDA changes
- MAPP
- EU variation
- Regulatory Software
- Lorenz Docu Bridge
- Lorenz eValidator
- Document Management
- RIMS
- PAS-X
- Collaboration Tools
- SAP
- FIORI
- MS Office
- Doc-Hub
Disclaimer
I do hereby declare that all the information given above is true to the best of my knowledge and belief.
Spouse
Yamuna
Personal Information
- Father's Name: Malakonaiah
- Mother's Name: Nagalaxmi
- Blood Group: O+ve
- Date of Birth: 06/15/91
- Nationality: Indian
- Marital Status: Married
Languages
English
Proficient (C2)
C2
Telugu
Native
Native
Hindi
Proficient (C2)
C2
kanada
Proficient (C2)
C2
Timeline
Team Member, Regulatory Affairs
Dr. Reddy's Laboratories
01.2022 - Current
Quality Specialist - Regulatory support
Granules India Ltd
01.2019 - 01.2022
Quality Specialist - Regulatory support
MSN Laboratories Pvt limited
01.2015 - 01.2019
M Pharm - Raichur
N. E. T. Pharmacy College
B Pharm - Bangalore
N. E. T. Pharmacy College
Intermediate - Ongole
Sri Pratibha Junior College
Matriculation -
Neredupalli High school