Sudha Tummalapalli
Hyderabad
Summary
Dynamic Regulatory Affairs Analyst with extensive experience at Dr. Reddy’s Laboratories, adept at preparing and submitting DMFs in CTD format. Proven ability to respond to regulatory queries and ensure compliance with ICH and USFDA guidelines. Strong analytical and communication skills drive successful cross-functional collaboration and regulatory strategy execution.
Seasoned Regulatory Affairs Analyst with comprehensive background in pharmaceutical and medical device industries. Strong ability to interpret regulations, develop strategies for product submissions, and manage regulatory activities. Notable strengths include strong analytical skills, adaptability, and communication proficiency. Successfully ensured compliance in previous roles and contributed significantly to the achievement of company objectives.
Overview
12
12
years of professional experience
Work History
Regulatory Affairs Analyst
Dr. Reddy’s Laboratories Ltd.
Hyderabad
03.2023 - Current
- Compilation and Review of regulatory submissions like USDMF, European DMF’s (ASMF/EDMF), CoS/CEP dossier, Canadian DMF, KDMF, Taiwan DMF, China DMF’s, Russia DMF’s and Brazil DMF’s in various formats by ensuring compliance with regulations pertaining to respective Health Authorities and ICH guidelines.
- Compilation & Review and submission of Initial filings, Annual Reports and Amendments submitted to USFDA.
- Compilation & Review and Submission of updated ASMF (AP & RP) to Europe countries by considering changes to ASMF.
- Compilation & Review and submission of applications for CEPs, Variations and Renewals for approved CEP to EDQM in line with the guidelines.
- Addressing the responses to the deficiencies received from various regulatory agencies and queries received from the various customers on Applicants Part of DMF.
- Organize the meetings with CFT teams to discuss about the way forward to arrange the response for the Deficiency comments received from the respective regulatory agencies.
- Responsible for handling the customer queries on Applicant’s Part Drug Master Files.
- Compilation & Review and submission of Applicnat’s part of the DMFs and Technical packages for the customers.
- Evaluation of products change controls through Track-Wise and giving regulatory comments on change implementation and requesting supporting data from Quality teams and accordingly planning for submissions.
- Collection and review of CMC documents received from various departments like QA, DQA, QC, R&D, AR&D and Production etc.
- Maintaining an adequate tracking system for submitted Regulatory documents such as Registration documents, DMFs, LoAs, Response to customer queries and deficiencies, STPs in an easily accessible manner.
- Preparation and submission of DMFs (Applicant & Restricted parts) in CTD format.
- Responding to regulatory and customer queries across various markets.
- Familiarity with ICH, USFDA, EU, TPD, MFDS, TGA guidelines.
- Evaluation of change controls and providing regulatory impact assessments.
- Maintenance of regulatory databases and tracking systems.
- Submission via eCTD and CESP (NeeS format).
- Issuance of LOAs for global customers (US, Canada, Europe, Australia, ROW).
Junior Manager – Regulatory Affairs
MSN Laboratories Pvt. Ltd.
Hyderabad
01.2019 - 03.2023
- Managed updates of USDMFs (amendments & annual reports), CEPs (quinquennial revisions, notifications), ASMFs, and Canadian MFs.
- Handled regulatory amendments involving process changes and vendor updates for global markets.
- Supported formulation teams with API documentation requirements.
Sr. Executive – API Development QA
MSN Laboratories Pvt. Ltd.
Hyderabad
04.2013 - 01.2019
- Reviewed DMF packages and supported documentation compilation.
- Participated in technology transfers and regulatory compliance meetings.
- Review of product development reports.
- Review of lab process validations.
- Review of Online documents of AR&D and R&D.
- Collaboration with CFT like AR&D, R&D and manufacturing sites.
- Handling product technology meetings.
Education
M.Sc. - Organic Chemistry
Osmania University
01.2012
B.Sc. - Biotechnology, Biochemistry & Chemistry
Osmania University
01.2010
Intermediate - Biology, Physics and Chemistry
Sri Vidhya College
Telangana01.2007
S.S.C. - LKG To Tenth
St. Joseph CCR Vidhya Nilayam
Telangana01.2005
Skills
- Preparation and submission of DMFs in CTD format
- Responding to regulatory and customer queries
- Familiarity with ICH guidelines
- Familiarity with USFDA guidelines
- Familiarity with EU guidelines
- Familiarity with TPD guidelines
- Familiarity with MFDS guidelines
- Familiarity with TGA guidelines
- Evaluation of change controls
- Providing regulatory impact assessments
- Maintenance of regulatory databases
- Tracking systems
- Submission via eCTD
- Submission via CESP
- Issuance of LOAs for global customers
- Proficient in eCTD publishing tools
- Strong working knowledge of MS Office
- Knowledge of regulatory validation
- Knowledge of e-submission processes
- Excellent analytical skills
- Excellent communication skills
- Strong interpersonal abilities
- Strong coordination abilities
- Self-motivated
- Adaptable
- Proactive
- Ability to prioritize tasks
- Ability to meet strict deadlines
- Regulatory submissions
- Regulatory compliance
- DMF preparation
- eCTD submissions
- Change control evaluation
- Technical documentation
- Customer relationship management
- Cross-functional collaboration
- Data analysis
- Problem solving
- Regulatory tracking
- Cross-functional teamwork
- Change control
- Global regulatory compliance
- Team collaboration
- Regulatory strategy
- Product development
- Multitasking ability
Languages
- English
- Hindi
- Telugu
Awards
Significant business support for commercial products.
Disclaimer
I hereby declare that the above information is true and correct to the best of my knowledge and belief.
Personal Information
- Date of Birth: 06/21/90
- Nationality: Indian
- Marital Status: Married
Approvals
- Received 5 CEP approvals for API specification changes, Safety process, Alternate vendor developments.
- One TFDA approval for Revised API specification and STP.
- One KDMF approval for change registration.
- 2 ASMF approvals.
Languages
English
Advanced
C1
Hindi
Intermediate
B1
Telugu
Proficient
C2
Timeline
Regulatory Affairs Analyst
Dr. Reddy’s Laboratories Ltd.
03.2023 - Current
Junior Manager – Regulatory Affairs
MSN Laboratories Pvt. Ltd.
01.2019 - 03.2023
Sr. Executive – API Development QA
MSN Laboratories Pvt. Ltd.
04.2013 - 01.2019
M.Sc. - Organic Chemistry
Osmania University
B.Sc. - Biotechnology, Biochemistry & Chemistry
Osmania University
Intermediate - Biology, Physics and Chemistry
Sri Vidhya College
S.S.C. - LKG To Tenth
St. Joseph CCR Vidhya Nilayam