Rama Krishna Kota
Hyderabad,Telangana
Summary
Results-driven Senior Regulatory Affairs (CMC) professional with 15+ years of progressive experience in global pharmaceutical regulatory strategy, CMC dossier management, and product lifecycle management. Proven expertise in developing and executing global CMC regulatory strategies for chemical entities and biological products across US FDA, EMA, and international Health Authorities. Demonstrated ability to lead cross-functional teams in matrix environments, manage complex regulatory submissions, and champion AI-enabled innovation in regulatory operations. Strong track record in regulatory risk assessment, stakeholder management, and regulatory intelligence monitoring.
Overview
16
16
years of professional experience
Work History
Senior Regulatory Affairs (CMC) Writer
Sanofi Healthcare India Private Limited
03.2025 - Current
- Developed and implemented global regulatory CMC strategies for marketed products, aligning with US FDA, EMA, and international Health Authority requirements to ensure compliance.
- Lead regulatory intelligence activities by monitoring new CMC regulations, communicating regulatory impact to manufacturing sites, and overseeing timely implementation of regulatory changes.
- Led Global Regulatory Lifecycle Management, identifying required CMC documentation changes in response to evolving regulations and coordinating compliant implementation across sites.
- Author, review, and approve high-quality CMC regulatory dossiers including renewals, annual reports, and Quality Overall Summaries (QOS), ensuring compliance with global regulatory standards.
- Facilitate cross-functional collaboration with R&D, Manufacturing, and Supply functions to ensure effective implementation of regulatory strategies and timely resolution of CMC issues.
- Maintain documentation accuracy by sourcing and compiling the latest CMC dossiers and post-approval changes from Sanofi databases; track site registration due dates and oversee site compliance progress.
- Championed AI-enabled tools and Power BI automation initiatives, enhancing efficiency and accuracy in regulatory operations through strong digital adoption.
- Deliver local training programs for sites on CMC regulatory requirements and IT tools, contributing to Global Quality reporting. Share best practices among technical writers to ensure consistency.
- Mentor and coach team members, building strong relationships and empowering a high-performance team culture.
Manager – Regulatory Affairs (CMC)
Freyr Software Services Private Limited
09.2022 - 02.2025
- Compiled and finalized regulatory submission dossiers (CTD/eCTD) for global markets, ensuring compliance with US FDA, EMA, and ROW Health Authority requirements.
- Developed global regulatory CMC strategies for products in re-development and lifecycle management phases, providing strategic input to development and commercial teams.
- Evaluated change controls, conducted impact analyses, and prepared variation strategies to support post-approval change submissions across global markets.
- Assessed regulatory CMC risks and opportunities, developed risk mitigation strategies, and communicated risk/benefit implications to project teams and senior stakeholders to facilitate informed decision-making.
- Responded to Health Authority deficiencies within specified timelines, ensuring scientifically sound, high-quality responses.
- Represented GRA CMC in global cross-functional teams (GRT, GPT), partnering with team leaders to facilitate successful product development and lifecycle management.
- Interfaced with Health Authorities for CMC submissions and related issues, fostering positive relationships and facilitating effective communication to support regulatory processes.
- Managed and mentored a team providing CMC regulatory support, communicating project plans, status updates, and regulatory insights to senior management and cross-functional stakeholders.
Scientist-II – Regulatory Affairs (CMC)
Aurobindo Pharma Limited
10.2016 - 08.2022
- Managed product lifecycle by filing Post-Approval Changes (CBE, CBE-30, Prior Approval Supplements) and Annual Reports with US FDA, ensuring continuous regulatory compliance.
- Reviewed ANDA documents including specifications, stability protocols, packaging plans, dissolution protocols, and photo-stability protocols; also reviewed technical documents (BMRs, BPRs, Hold Time Study Protocols, AMV, AMTR) for regulatory compliance.
- Evaluated DMF notifications from DMF holders and coordinated with QA, QC, FR&D, FAR&D, and Procurement to compile complete document sets for ANDA submissions and deficiency responses.
- Assessed regulatory inputs for assigned change controls and reviewed scientific justifications for regulatory submissions.
- Reviewed Product Development Reports, Master Formulation Records, and Analytical Method Validation Protocols and Reports per USP, Ph.Eur., and ICH guidelines.
- Delegated tasks to team members, facilitating timely completion of annual reports and supplements.
Executive – Regulatory Affairs
Adcock Ingram Private Ltd.
12.2015 - 09.2016
- Compiled and prepared high-quality CTD dossiers including labeling per South Africa MCC and country-specific requirements; prepared quality responses to agency queries and reviewed DMFs, CEPs, and relevant documentation per MCC guidelines.
- Liaised with manufacturing sites, customers, and principals to ensure timely completion of product dossiers by obtaining necessary documents.
- Managed documentation per internal practices, ensuring compliance and quality of dossiers per MCC and country guidelines.
Executive L-2 – Regulatory Affairs (US Market)
Leiutis Pharmaceuticals Pvt. Ltd.
07.2013 - 11.2015
- Compiled ANDA submissions per eCTD requirements and coordinated with R&D, AR&D, and QA departments to deliver high-quality documentation, ensuring compliance and readiness for regulatory review.
- Prepared ANDA documents for oncology products (lyophilized injections, liquid injections, oral solid dosage forms), contributing to successful regulatory submissions through analytical method development, validation, and transfer activities.
- Reviewed DMFs, BMRs, technical summary reports, quality risk assessment reports, and product development reports; conducted internal audits and crafted comprehensive responses to regulatory queries to support compliance.
Junior Scientist
Natreon Inc.
Kolkata
01.2011 - 06.2013
- Conducted research and development on isolation of biomarkers, developed analytical methods, and performed quality analysis of products to ensure reliability and accuracy.
- Conducted experiments to analyze natural product efficacy and safety.
- Maintained laboratory equipment and ensured compliance with safety standards.
Education
M. Pharmacy -
Gokaraju Rangaraju College of Pharmacy
Hyderabad09-2010
B. Pharmacy -
Vaagdevi College of Pharmacy
Warangal09-2007
Skills
- Global regulatory strategy development
- FDA and EMA liaison
- Dossier preparation and approval
- Post-approval change management
- Regulatory risk assessment
- Cross-functional team leadership
- Regulatory intelligence monitoring
- Product lifecycle management
- Digital tools in regulatory affairs
- Stakeholder management and negotiation
- Veeva Vault, MS Office
- Mentoring and team development
- Regulatory compliance frameworks
- Strategic thinking and decision-making
- Regulatory systems: Veeva Vault, PLai, PharmaReady, Lorenz, DocuBridge, TrackWise QMS, DMS
LANGUAGES
English (Professional) | Hindi | Telugu
Disclaimer
I hereby declare that the information provided above is accurate and true to the best of my knowledge. Rama Krishna Kota
Timeline
Senior Regulatory Affairs (CMC) Writer
Sanofi Healthcare India Private Limited
03.2025 - Current
Manager – Regulatory Affairs (CMC)
Freyr Software Services Private Limited
09.2022 - 02.2025
Scientist-II – Regulatory Affairs (CMC)
Aurobindo Pharma Limited
10.2016 - 08.2022
Executive – Regulatory Affairs
Adcock Ingram Private Ltd.
12.2015 - 09.2016
Executive L-2 – Regulatory Affairs (US Market)
Leiutis Pharmaceuticals Pvt. Ltd.
07.2013 - 11.2015
Junior Scientist
Natreon Inc.
01.2011 - 06.2013
M. Pharmacy -
Gokaraju Rangaraju College of Pharmacy
B. Pharmacy -
Vaagdevi College of Pharmacy