Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Information
Languages
Training
Disclaimer
Key Strengths
Regulatory Knowledge
FAVOURABLE PERSONALITY TRAITS
Timeline
Generic

J VENKATESH

Hyderabad

Summary

Regulatory affairs professional with 11 years of experience in the pharmaceutical industry. Experienced in regulatory strategy, including dossier preparation, query response, post-approval compliance, renewals, and new submissions across global markets. Proven track record of managing changes, stakeholder management, and mentoring. Experienced in project planning, prioritizing requirements, and quality management. Acquired knowledge in documentation and quality management. Effective collaboration, organizational skills, and attention to detail. Passionate about delivering desired goals through effective communication and teamwork.

Overview

12
12
years of professional experience

Work History

Lead Consultant CMC

Genpact India PVT limited
Hyderabad
09.2023 - Current
  • Responsible for product life cycle management renewals and new submissions for global markets.
  • Served as an SME for handling customer-specific tools, such as Veeva Vault and Synapse.
  • Change control assessment, review, and approval for the assigned molecules.
  • Assisted in filing variations for a wider range of markets, for example, site transfer. Gap assessment and to strategize the submission.
  • Sharing knowledge and learnings across the team, and participating in team-building activities. Training new joiners and doing quality checks of dossiers.
  • Effectively collaborate with stakeholders on project submission status, ensuring that the agreed timeline is met according to client requirements.
  • Acts as the main contact during the submission preparation, execution phase, and initial submission of the project.
  • I worked on NDA and IMPD submissions for global customers.
  • Presented findings and proposals to senior management and clients effectively.
  • Led meetings with internal teams and external partners as needed.

Senior Consultant CMC

Syneos Health Care
Hyderabad
06.2021 - 09.2023
  • Regulatory Intelligence and Strategy filing for customers globally.
  • CMC support for handling post approval changes for global customers.
  • SME for handling customer specific tools like Veeva Vault, Orion etc.
  • Change control assessment/review and Approval for the assigned molecules.
  • Assisted in filing variations for wider range of markets example site transfer.
  • Sharing knowledge and Learning across the team and participated in team building activities.
  • Effectively collaborate with stakeholders in project submission status and ensuring to meet agreed timeline as per client requirements.
  • Provided regulatory intelligence or filing support for Antivenins as an additional activity.

Specialist in Regulatory Affairs

Sandoz India Limited
Hyderabad
10.2019 - 06.2021
  • Preparing and submitting dossiers to the global markets.
  • Preparing and reviewing the CMC section (Module 3).
  • Preparation and submission of baseline submissions, and post-approval changes in Europe and ROW.
  • Providing responses to the deficiencies during the approval procedure.
  • Ordering Module 1 documents based on submission and country requirements.
  • Responsible for eCTD compilation and publishing.
  • Regulatory strategy and gap assessment during filing, and product life cycle management.
  • Tracking submission and approval status internally, and updating the database.

Executive in Regulatory Affairs

Hetero Drugs Limited
09.2016 - 10.2019
  • Reviewing product dossiers, reviewing technical documents like DMF, analytical reports, validation protocols and reports, master formula records, batch manufacturing records, and stability.
  • Preparing and submitting dossiers to the European market, focused through various procedures.
  • Preparing and reviewing the CMC section (Module 3).
  • Preparation and submission of post-approval changes in Europe.
  • Change controls management, including review and approvals.
  • Handling market non-compliance and batch release issues with QP.
  • Providing responses to the deficiencies during the approval procedure.
  • Responsible for eCTD compilation and publishing.
  • Regulatory strategy during filing, and product life cycle management.
  • Handled site transfer projects from Europe to India, gap analysis, project management, filing changes, and active communication with stakeholders are part of this project.

Officer in Regulatory Affairs

Mylan Laboratories Limited
Hyderabad
09.2015 - 05.2016
  • Reviewing product dossiers, reviewing technical documents like analytical reports, process validation protocols, master formula records, batch manufacturing records, and stability data.
  • Handled queries raised by various regulatory bodies.
  • Preparing and submitting ANDA dossiers according to country-specific guidelines.
  • Preparing and reviewing the CMC section (Module 3).
  • Regulatory support in filing the dossier and post-approval changes for the U.S. and Europe.
  • Review of labeling data as per country-specific requirements.
  • Review and authorization of labeling artwork and their scientific information for regulated markets.
  • Regulatory strategy for filing submissions.

Junior Technical Officer in Regulatory Affairs

Brilliant Bio Pharma LTD
Hyderabad
10.2013 - 07.2015
  • Preparing and submitting ANDA dossiers according to country-specific guidelines.
  • Preparing and compiling product dossiers in CTD formats for semi-regulated and ROW markets.
  • Reviewing product dossiers, reviewing technical documents like analytical reports, process validation reports, process validation protocols, batch manufacturing records, pharmaceutical development reports, and stability data.
  • Coordinating with R&D, QC, and QA departments to obtain the technical information.
  • Handled queries raised by various regulatory authorities.
  • Have a sound knowledge of quality module (CMC) writing and review, together with strategy-making for quality changes.
  • Maintaining the product registration and renewal status globally.
  • Legalization of registration documents from the respective embassy.
  • Preparation, review, and authorize the labeling data as per country requirements.
  • Preparing scientific data required for labeling, and assisting in the preparation of package inserts.
  • Preparing product technical sheets and technical documents as per the regulatory guidelines, and participating in tenders globally.
  • Participating in the presentation of the products to the customers globally.

Education

M.PHARMACY -

VIKAS COLLEGE OF PHARMACEUTICAL SCIENCES
01.2013

B.PHARMACY - Pharmaceutical Sciences

BASAVESHWARA COLLEGE OF PHARMACY
Karnataka
11-2011

Skills

  • Regulatory – CTD and eCTD submissions
  • IT Competency – MS Office (Word, Excel, Power point)
  • IT Research Competency - proficient in the use of Internet and on-line retrieval systems for information research
  • Project management
  • Change control
  • Submission preparation
  • Regulatory strategy
  • Stakeholder collaboration
  • Training and mentoring
  • Product life cycle management

Accomplishments

  • Received a bronze medal for the performance and multitasking in handling and delivering the projects
  • Received appreciation from the client for handling IND submissions globally

Personal Information

Languages

5,C1,6,C2

Training

  • Undergone Extensive training in Regulatory affairs (ICH guidelines, CTD overview, Regulatory requirements)

Disclaimer

I hereby declare that the above mentioned details are true to my best knowledge. If given a chance, I can prove the best of my potentials.

Key Strengths

  • Ability to work effectively in a team and flexible to meet challenges under pressure.
  • Superior communication, diagnostic, technical, and presentation skills.
  • Good Understanding with Pharmacovigilance, Clinical Research to Professional Development like Leadership, Team Work, Communication, Integrity, Performance.
  • Good understanding on Drug Regulatory Affairs requirements in compliance with ICH

Regulatory Knowledge

  • General overview of Regulatory Affairs in pharma industry.
  • Regulatory aspects in Pharmacovigilance
  • ICH guidelines overview
  • Common Technical Document Overview – Modules
  • Regulatory Authorities around the Globe.

FAVOURABLE PERSONALITY TRAITS

  • Commitment to work, adaption ability.
  • Goal oriented person, Quick learner and hardworking Comfortable with teamwork.

Timeline

Lead Consultant CMC

Genpact India PVT limited
09.2023 - Current

Senior Consultant CMC

Syneos Health Care
06.2021 - 09.2023

Specialist in Regulatory Affairs

Sandoz India Limited
10.2019 - 06.2021

Executive in Regulatory Affairs

Hetero Drugs Limited
09.2016 - 10.2019

Officer in Regulatory Affairs

Mylan Laboratories Limited
09.2015 - 05.2016

Junior Technical Officer in Regulatory Affairs

Brilliant Bio Pharma LTD
10.2013 - 07.2015

M.PHARMACY -

VIKAS COLLEGE OF PHARMACEUTICAL SCIENCES

B.PHARMACY - Pharmaceutical Sciences

BASAVESHWARA COLLEGE OF PHARMACY

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