CURRICULUM VITAE

Chakradhar Reddy: +91 8073845078

Email: chakradharreddy05@gmail.com
Career objective
A career that is enriching in terms of inputs which provides ample scope for employing
my abilities to achieve constant advancements and to work for the betterment of the
organization. Diligent and results-driven Regulatory Affairs Associate with specialized
expertise in Chemistry, Manufacturing, and Controls (CMC) and a demonstrated
proficiency in handling ANDA queries and obtaining approvals for the US market.

Experience Profile
Total Experience: 3 years 2 months
Role Summary

Experience/Role Summary • Regulatory Affairs Executive at Micro Labs Limited

(From June 2022 – till present)
• Regulatory Affairs Trainee at Shilpa Medicare Limited
(From Oct 2020 – June 2022)

1. Shilpa Medicare Limited

Designation : Trainee Duration: Oct 2020- Jun-2022

Department : Regulatory Affairs
Markets : ROW
Location : Hyderabad
Responsibilities:
 Preparation of Dossiers in line with the registration requirements of various semi
regulated/Non-regulated markets. Preparing the CTD & ACTD, Country specific
format dossier for oral dosage forms for emerging markets.
 Coordinate with concerned departments like Quality Control, Quality Assurance,
production and Research Development for compilation of technical dossiers and meet
the submission timelines.
 Coordinating in the sample management and submission to the regulatory authorities.
 Data base management for submitted dossiers/Documents/Samples.
 Review of labeling & packaging materials, Package insert for the finished formulation
under supervision.
 Timely response to queries raised by various clients and regulatory authorities.
 2. Micro Labs Limited

Designation : Executive Duration: June 2022 - till present

Department : Regulatory Affairs
Markets : US
Location : Bengaluru
Responsibilities:
• Spearheaded successful regulatory submissions and obtained approvals for various
dosage forms such as tablets, capsules, modified release tablets, Oral Suspension and
Oral solutions adhering to USFDA regulations and guidelines.
• Led the compilation and preparation of M1 to M3 modules for ANDA submissions,
ensuring compliance with USFDA guidelines and the Electronic Common Technical
Document (eCTD) format.
• Collaborated effectively with cross-functional teams, including R&D, Quality
Assurance, and Manufacturing, to address technical challenges raised by USFDA
during the review process, ensuring compliance and optimal outcomes.
• Developed and implemented strategies to align the company's regulatory practices
with the latest USFDA and ICH guidance's, ensuring compliance with evolving
standards and industry best practices.
• • Proactively managed workload, timelines, and identified priorities, demonstrating
excellent organizational skills.
• Built strong relationships with internal functions, fostering effective collaboration
across teams.
• Demonstrated a broad understanding of the pharmaceutical industry, drug
development environment, and R&D processes and objectives.
• Demonstrated expertise in handling complex queries from the USFDA leading to
successful resolution and timely approvals.
• Collaborated with contract manufacturing organizations and Contract Testing
Laboratories to address CMC-related issues identified during USFDA queries,
ensuring adherence to regulatory standards and resolving observations.
• Involved in writing controlled correspondences to USFDA.
• Responsible for reviewing of all approved quality study reports required for
submission.
• Review of the change controls and knowledge on QAMS Software.
• Review of the R&D Specifications and Standard Test Procedures on DMS Software.
Regulatory Knowledge

 A career that is enriching in terms of inputs which provides ample scope for
employing my abilities to achieve constant advancements and to work for the
betterment of the organization.
 Diligent and results-driven Regulatory Affairs Associate with specialized expertise
in Chemistry,Manufacturing, and Controls (CMC) and a demonstrated proficiency
in handling ANDA queries and obtaining approvals for the US market.
 In-depth knowledge of CMC regulations and guidelines, including USFDA and
ICH guidance's, driving successful approvals for various pharmaceutical products.
 Identifying reference products for various markets for generic application.
 Tracking relevant citizen petitions and suitability petitions for molecules under
pipeline Good Knowledge on RTR guidance of ANDA submission

Technical Expertise
 CMC (Module-1,2 and 3) of ANDA for US Market.
 Knowledge of Publishing Tools- PHARMAREADY and LORENZ Validator.
 Regulatory life cycle management for US market.
 Stakeholder management and strategic planning for regulatory submissions.
 Well Versed in ICH Guidelines quality and knowledge of USFDA guidelines.

Personal abilities
 Keen observation and proper analysis of the problem.
 Ability to work in a team, discipline and punctuality.

Computer proficiency
 Fundamental knowledge on operating systems Windows.
 Well Versed with MS Office such as Word and Power Point.
 Knowledge in publishing tools – Pharmaready and Lorenz Validator.

Educational Qualification:

Year of Percentage (%)

Course University Institution
Passing obtained
Rajiv Gandhi
V L College of
M. Pharmacy University of
pharmacy,
(Pharmaceutics) Health Sciences, 2020 83.00%
Raichur
Bengaluru
Rajiv Gandhi
V L College of University of
B. PHARMACY pharmacy, 2018 62.00%
Health Sciences,
Raichur Bengaluru
Vidya Bharathi Department of Pre
PUC PU University 2014 49.00 %
college Raichur Education
SSLC VSVN School KSEEB 2011 77.12 %
Gandhinagar
Personal Details:
Name : Chakradhara Reddy Satti
Date of Birth : 10th March 1995
Sex : Male
Languages Known : English, Kannada, Hindi, and Telugu
Permanent Address : Gandhinagar village, Sindhanoor (Tq) and Raichur (Dt)
Karnataka 584128.

Declaration:

The information which I have given above is true with proper documentation evidence.
In view of the above, I request you to be kind enough to give me an opportunity to
serve in your esteemed organization. Thank you.

Place: Bengaluru Chakradhara Reddy Satti

Date: