Saratkumar Elluru
Regulatory Affairs Manager
Bangalore
Summary
Aspiring professional eager to leverage skills and expertise within Regulatory Affairs, fostering innovation and resourcefulness while pursuing career advancement.
Overview
15
15
years of professional experience
2
2
Certifications
4
4
Languages
Work History
Manager in Regulatory Affairs
Baxter Innovations and Business Solutions Pvt. Ltd.
07.2019 - Current
- Managing the group of people in a team and mentoring them on change control assessments, variation submission activities for both Drugs and Devices, renewals, GeoX, re-registrations, PSURs, Labelling, and monitor daily operations of team in an efficient manner.
- Co-ordination and execution of regulatory and CMC strategy for different components of regulatory submissions (NDAs, ANDAs, sNDAs, MAAs).
- Checking the MDR Technical Documentation File, GSPR Check list, Essential principal checklists, Declaration of Conformities, USFDA 510(K), 513g, Letter to File submissions and Post Market Surveillance documents for DHF Remediation activity.
- Reviewing regulatory dossiers for drug registration in India, ensuring compliance with CDSCO guidelines. Managed query responses and correspondence with CDSCO via SUGAM portal.
- Liaise closely with cross functional team with aligned product responsibilities.
- Responsible and accountable for creating and driving the execution of the project regulatory plan.
- To manage end-to-end processes within RA for all changes involving Global products.
- High Proficiency in Trackwise tool to handle Global change controls.
- Engage with Global Business Units and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements.
- Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).
- Review, edit and proofread regulatory documentation.
- Responsible for preparing metrics and sharing with the leadership team for overall Business Segments and Divisions.
- Responsible for review of product design and labelling changes of Medical Devices for international markets.
- Successfully received 200+ Global variation approvals from different health authorities.
Specialist in Regulatory Affairs
Imed Global Solutions India Pvt. Ltd., now rebranded as ClinChoice Inc.
02.2018 - 07.2019
- Preparation and Review of Module 1, 2 & 3 in Europe for drug product registrations.
- Co-ordination with cross functional teams for collection and review of documents which are required for authoring of CMC sections.
- Change control assessments through Trackwise and Symphony tools.
- Preparation, review and timely submissions of Variations such as Type IA, IAIN, IB, II, Grouping and work sharing submissions in Europe.
- Preparation of RAN (Regulatory Authorization Notification) as and when the variation got approved from Health Authority and circulate the same to manufacturing site for their awareness and implementation.
Associate-II in Regulatory Affairs
Apotex Research Private Ltd.
02.2014 - 02.2018
- Preparation of Module 1 to 3 for drug product registrations in Europe and USA.
- Preparation, review, and timely submission of variations (Minor, Moderate, Major) to Europe, US, Canada, Australia, and New Zealand Health Authorities.
- Timely, and actively support for Health Authority Queries.
- Preparation and Submissions of annual reports for US and Canada markets.
- Review of all technical documents required for authoring original submissions, variations and query responses.
- Assessing CMC change controls for approved drug products through Trackwise for Regulated markets.
Officer I in Regulatory Affairs
Genovo Development Services Limited (Medreich R&D centre)
11.2011 - 02.2014
- Authoring of CMC sections for Europe registrations.
- Co-ordination with Formulation, Analytical, and Quality departments for collection of technical documents which are required for regulatory submission.
- To understand and analyze deficiencies and prepare responses to the deficiencies received from health authorities to expedite the approval process.
- Review of Product Development reports as per the filing requirements.
- Review of technical documents such as Master Formula Records, Specifications, analytical methods, CoAs, Batch records, and Validation reports etc.
- Timely review of exhibit batch stability reports and preparation of stability sections for filing extension of shelf-life.
- Constantly enhance the quality of submissions by keeping in mind the learning’s from the past deficiencies/diligences.
Project Trainee
Genovo Development Services limited
11.2010 - 04.2011
- Underwent industrial training in Regulatory Affairs and Formulation department for a period of 6 months.
Education
M.Pharmacy - Pharmaceutics
Annamacharya College of Pharmacy
Rajampet06.2011
Skills
Regulatory guidelines expertise
Agency query resolution
Mentorship and leadership
Team management and communication
Project management proficiency
Regulatory tools expertise
Certification
Certified Internal Auditor - ISO 13485:2016 (Medical Device Quality Management System)
DECLARATION
I hereby declare that the information furnished above is true to the best of my knowledge. Date : Place : Bangalore With Best Regards SARATKUMAR ELLURU
Accomplishments
Consistently scored above 90% rating in all Manager Effectiveness Surveys, demonstrating exceptional leadership and people management skills.
Recognized as Best employee for two consecutive years
Timeline
Manager in Regulatory Affairs
Baxter Innovations and Business Solutions Pvt. Ltd.
07.2019 - Current
Specialist in Regulatory Affairs
Imed Global Solutions India Pvt. Ltd., now rebranded as ClinChoice Inc.
02.2018 - 07.2019
Associate-II in Regulatory Affairs
Apotex Research Private Ltd.
02.2014 - 02.2018
Officer I in Regulatory Affairs
Genovo Development Services Limited (Medreich R&D centre)
11.2011 - 02.2014
Project Trainee
Genovo Development Services limited
11.2010 - 04.2011
M.Pharmacy - Pharmaceutics
Annamacharya College of Pharmacy