Mogali Rambabu
International Pharma Regulatory Affairs and Quality Auditor
Hyderabad
Summary
- 27+ years’ rich experience in International Pharma Regulatory affairs (filings geographically with USFDA, EU, MHRA, UK, EDQM, WHO Geneva, IRAN MOH, Health Canada, Australia, South Korea, Russia, China, South Africa, and Japan etc.
- Having rich exposure and experience in leadership role as Head of the department of Quality and Regulatory Affairs.
- Rich experience as Quality Auditor
- Experience in handling of several major Regulatory and Customer quality audits with respect GMP (more than 500+ new molecules/APIs)
- Achieved all time management goals during my tenure for regulatory submissions to get faster approvals.
- High quality DMF Drafting and Scientific justifications to get regulatory approvals in timely.
- Rich experience in conducting Vendor quality audits.
- Lead the team members and drive the regulatory strategies / company goals and responsible for execution of projects for CMC review, ensure the technical requirements
- Further, to my credit, more than 500+ products DMF submissions of various category molecules to support the Generic and NCE-1 products (first to file)/ ANDA filing, 180 days exclusivity etc.) for global customers.
- A proven track record of fast & favorable approvals in all the regions and extraordinary performance in every year in my entire service.
- Active in technical and key role as decision maker to resolve technical, quality and regulatory issues and trouble shootings. Ensure effective regulatory compliance with respect to the Original and Life cycle Management for all regulatory filings globally.
- Expert in CMC review of drug development and lifecycle management and fixing the regulatory strategy.
- Having experience to mentor/ continuous trainings to the technical team / Cross functional Teams for quality and regulatory compliance.
- Providing necessary Regulatory Support during the Health Authorities Quality cGMP Inspections to plant personnel.
- Experience in performing MocK USFDA audits
Overview
26
26
years of professional experience
1
1
Language
Work History
Dy. General Manager-International Regulatory affairs
Aurobindo Pharma Limited
03.2022 - 10.2024
- Senior Leadership role as Dy. General Manager-International Regulatory affairs in Aurobindo Pharma API division. Responsible for USA, EU, Canada, Japan and Australia markets.
Dy. General Manager-International Regulatory Affairs
Amneal, USA
04.2011 - 03.2022
- Senior Leadership role for all regulatory functions as Dy. General Manager-International Regulatory affairs in Amneal Pharmaceuticals for API division. Responsible for USA, EU, Canada, Japan, S. Korea, South Africa, Russia, China, Taiwan, Vietnam, and Australia markets. Worked as Manager, Sr. Manager, Asst. General Manager and Dy. General Manager-International regulatory Affairs.
- Established RA department, initiated to start the filing of USMF’s, CEPs and Globally. Further, supported the preparation and review of Quality Management systems to comply the cGMP standards and current regulatory requirement. Participated as key role in USFDA, EDQM and cGMP audits.
- Proven track record on high level professional performance (all the time extraordinary performance which is more than outstanding performance).
Dy. Manager-International Regulatory affairs
Natco Pharma Limited, India
11.2008 - 04.2011
- Leadership role as Dy. Manager-International Regulatory affairs for API division Pvt. Ltd. Responsible for USA, EU, Canada, S. Korea, Russia, and Australia markets.
Assistant Manager-International Regulatory Affairs
Mylan Inc USA
07.2005 - 10.2008
- Responsible for Mylan Uni-8 products leadership role as Assistant Manager-International Regulatory affairs and Quality Audits compliance for API division located in Vizianagaram. Responsible for USA, EU, WHO Geneva, Canada, Australia and Japan markets.
- Rich exposure and experience in Pharma Quality Management for Quality and Compliance.
- Having creative skills, & implementation of the cGMP Quality management systems / standards to meet the) ICH Quality., 21CFR, CEP, EU GMP guidance.
Responsible for QA and RA activities
Neuland Laboratories Limited, Hyderabad
07.1998 - 07.2005
- Responsible for QA and RA activies; Actively participated as Key and responsible member in Quality /GMP audits conducted by Regulatory Authorities (i.e., 8-USFDA, 2-EDQM, 3-WHO-Geneva, 1- KFDA, 1-TGA-Australia and more than 250 regulatory customer’s GMP/Quality audits and improved the knowledge on Quality Management systems and regulatory requirement accordingly.
- Extended contribution in supporting to various marketing authorization applications of European Union [National/MRP/DCP], USFDA [NDA/ANDA], EDQM, France TPD-Canada [INDS/ANDS], TGA-Australia, Korean FDA, Taiwan, FDA PMDA-Japan and other regulatory authorities’ requirements.
Education
M.Sc. - Chemistry
Skills
Started my career in the year 1998 as Trainee chemist in API manufacturing facility and got 26 years high quality and rich experience During my tenure from 1998, I got high quality exposure
Strong in Regulatory and Quality Management Systems (QAS), Technical discussion, technical documents review, drafting in drug master files, to meet global regulatory expectations
Strong knowledge in ICH guidelines
Experienced in conducting Quality audits and worked sd QP auditor
Creation of innovative internal regulatory tools to improve the day-to day activities to submit quality DMFs (Ex: Road map for regulatory requirement etc) and Regulatory trainings and expert advice
Planning, follow-up, active participation with cross functional team in a smooth manner by giving the regulatory guidance to the team for achieve the desired output as per the timelines
Worked as team leader to prepare the Nitrosamine risk assessment reports as per the current regulatory compliane (leaded to 350 risk assessment reports preparation, review and conclusions)
Regulatory strategy and preparation of Road map for execution and compliance to regulatory guidelines to serve quality DMF
Worked in oriented system-based approach with commonsense, proactive and positive attitude to meet the regulatory compliance
Ensuring regulatory compliance for the facility and regulatory submissions (such as ensuring GDUFA fee Self-id, renewals of LCMs etc, NDC label filings etc)
Leading the cross-functional team on regulatory aspects
Technical Documentation
Risk management
Process validation, design on GMP protocols, Analytical Method validations, Quality risk Management, SOP generation, Technical writing for prepartion of drug master files, dossiers and Responses to Regulatory queiries, CAPA, change Management, Due deligence,
Accomplishments
- 1. More than 200 GMP audits conducted and successfully completed the assessment and concluded.
- 2. Several regulatory audits faced (i.e., more than 20 USFDA, 6 WHO 10 EU Agencies,2 Korean FDA, 5 TGA and more than 200 major FDF customers and success fully complied all the required items as per the norms.
- 3. Successfully completed IRA MoH audits
- 4. Membership- International Quality, regulatory and scientific advisor in GLG (Gerson Lehrman Group) in the world’ expert insight Network.
- Worked as a lead auditor for GMP audits to severial manufacturing companies.
- Trained Quality Auditor Internal and external.
Disclaimer
I hereby declare that, the above particulars are true and correct to best of my knowledge and belief Mogali Rambabu Date: September-5, 2025 Hyderabad
Specialties
- Lead the new challenges for Global regulatory compliance by applying innovative thoughts and minimize the regulatory queries or to support for expeditious approvals.
- I have an attitude of commitment to work with dedication and honesty and proved in the profession.
Personnel details
- Name : Mogali. Rambabu
- Date of birth 1st July, 1975
- Gender : Male
- Marital status : Married.
- Qualifications : M.Sc. (Chemistry)
- Other Technical: Computer knowledge in MS Office (MS WORD, EXCELL)
- Type writing English 30 words/minute (Lower passed certified).
- Experience in Power point presentations
- Experience in eCTD (educe)
- Nationality Indian
- Languages English, Hindi and Telugu
- Permanent Address M. Rambabu Lakshm’s emperia Near Stanford School Flat D209, Miyapur Hyderabad-49
Timeline
Dy. General Manager-International Regulatory affairs
Aurobindo Pharma Limited
03.2022 - 10.2024
Dy. General Manager-International Regulatory Affairs
Amneal, USA
04.2011 - 03.2022
Dy. Manager-International Regulatory affairs
Natco Pharma Limited, India
11.2008 - 04.2011
Assistant Manager-International Regulatory Affairs
Mylan Inc USA
07.2005 - 10.2008
Responsible for QA and RA activities
Neuland Laboratories Limited, Hyderabad
07.1998 - 07.2005