Shaik Azeem Ahmed
Senior Regulatory Consultant
Bengaluru
Summary
Experienced regulatory affairs professional with a proven track record in managing and delivering high-quality regulatory submissions, including CMC documentation in eCTD format, for global markets such as the US, Europe, Canada, and Greater China. Demonstrates expertise in regulatory governance, health regulatory compliance, and lifecycle management through roles at leading organizations like Novartis and Parexel. Proficient in tools such as DRAGON, CARA, Veeva Vault, Verity, Reg Point, Lorenz Docubridge, Dossplorer and Agile project management systems. Career focus includes driving excellence in regulatory operations to support product registrations and lifecycle maintenance on a global scale.
Overview
8
8
years of professional experience
2011
2011
years of post-secondary education
10
10
Languages
Work History
Senior Regulatory Consultant
Conntinuum India
Chandigarh
05.2025 - Current
- Work with global clients on regulatory filing projects for USFDA, EMA, MHRA, APAC, Canada, etc. The key delivery areas include pre- and post-approval CMC authoring, preparation, and submission.
- Scientific writing, review, and compilation of submission documents, like the quality overall summary (Module 2), CMC quality drug product, drug substance, and regional information (Module 3).
- Independently author and/or coordinate CMC activities for new registrations, post-approval changes (minor, moderate, and major), renewals, annual reports, and line extensions to meet filing requirements. Coordinating and contributing to responses to agency queries, and performing quality review of regulatory CMC submissions.
- Deliver projects in either pharmaceutical, consumer products, or over-the-counter (OTC) drug products, as per client portfolio requirements.
- Ensure timely delivery of error-free, high-quality CMC documents that meet international standards of written English, and relevant technical requirements, following internal/client-specific style guides/templates.
- Demonstrate expertise in planning CMC submissions, including appropriate knowledge management tools such as Veeva Vault and Reg Point.
- Assist in CTD and non-CTD submissions using tools, e.g., Lorenz Docubridge, Dossplorer.
- Demonstrate an in-depth understanding of content requirements, including awareness and understanding of CTD format, and apply expertise to ensure global regulatory commitment tracking.
- Work cross-functionally and in collaboration with key stakeholders, both internal and external.
Senior Regulatory Co-Ordinator
Novartis
09.2023 - 05.2025
- Responsible for the compilation, review, and ensuring the high-quality chemistry, manufacturing, and control (CMC) documentation in eCTD format for regulatory submissions to the US market.
- Coordinating and handling the compilation and post-approval submission, i.e. CBE‐30 and CBE‐0 to USFDA, using appropriate guidelines and regulations to maintain product life cycle.
- To review and compile analytical documents: drug substance, drug product, excipients specification, STP, COAs, residual solvent data package, method validation, verification, transfer reports, stability data, and stability commitment.
- Ensures excellence in planning and productivity for the timely delivery of critical regulatory post-approval (variations) submissions for product manufacturing site transfers.
- Responsible for registration samples and various regulatory authorised documents for the rest of the world (RoW), Latin America, Canada, the Europe region (non-EU countries), and the Greater China region, as per requirement.
- Ensuring the various key regulatory components for non-CMC requirements such as supporting certificates, GMP, registration samples, and COAs as needed to achieve marketing authorisation and life cycle maintenance in collaboration with the following other line functions.
- Delivers operational support to regulatory activities related to new product registration, and production transfer.
- Manage excellent interaction and collaboration with RA colleagues in country levels (CPOs) for regulatory maintenance activities.
- Prompt and complete responses to regulatory-relevant queries from various stakeholders (e.g., regulators, compliance officers, and legal teams). regulators, auditors and internal teams.
HAs, CPOs) relating to assigned activities. - Maintenance of up-to-date country requirement lists and plans covering activities in scope through conducting need-based surveys and interaction with CPOs.
- Worked on different systems and tools (e.g. DRAGON, Esquire and Agile.
- Scheduled meetings, prepared agendas, and distributed minutes to ensure all participants were well-informed.
Regulatory Affairs Associate
Parexel International Pvt.Ltd
08.2021 - 08.2023
- Authoring of variation package for global markets for multiple dosage forms.
- Response to the queries to the health authority within given time frame.
- Annual report submissions for the impacted markets based on assessment.
- Coordination with relevant cross functional team for the documents/information required for the dossier.
- Change control assessment for global markets.
- Working on tools CARA, Verity, Trackwise, CSI portal etc. efficiently.
- Worked on Veeva Vault for Lifecycle Management and other events such as Change Control Assessment, HA Query Creation and Creating Content Plan.
Regulatory Affairs Specialist
Accenture Solutions Pvt Ltd
01.2021 - 07.2021
- Track status and progress of regulatory documentation for product renewals
- Maintenance of database of Regulatory Requirements for renewals
- Interaction with non-regulatory teams for supporting documentation of renewals
- Management and compilation of responses to regulatory authority queries.
Regulatory Affairs Associate
Cortis MedTech Pvt Ltd
09.2020 - 12.2020
- Management of relationships with notified bodies and regulatory agencies e.g BSI, FDA, Health Canada, TGA, MHRA
- Product and supplier registrations for new and existing markets including: USA; Canada; & Europe
- Preparation, maintenance and management of technical files to support CE marking of medical devices and non-medical electronic products
- Management of significant changes with notified bodies and regulatory agencies
- Transition strategy, planning and implementation for New MDR
- Writing of new QMS Processes for regulatory compliance, and prepare, execute and write up of Audits
- Management of CAPAs and Deviations.
Regulatory Affairs Officer
Adcock Ingram, Relicare Tech Services Private Limited
04.2019 - 08.2020
- Ensure compilation & preparation of a high quality CTD dossier including labelling as per specific country requirements.
- Ensure preparation of quality responses to agency queries timeously suitable to be filed.
- Ensure documentation management according to internal organization practices.
- Ensure quality review of all kinds of dossiers as per current SAHPRA /specific country guidelines
- Compile dossiers for pre & post approval variations.
- Review of DMF/CEP and all other relevant documentation according to SAHPRA/specific country requirements.
- To coordinate with R & D, QA,QC and production for documents
- To circulate checklists for dossier requirements.
Associate Professor
Oxbridge College of Pharmacy
05.2018 - 04.2019
Education
M.Pharm - Quality Assurance
Al-Ameen College of Pharmacy
BengaluruB. Pharm -
KLE University College of Pharmacy
BengaluruPre University - PCMB
CMR National PU College
BengaluruHigh School Diploma -
Noble Saint English School
BengaluruSkills
Proficient in Microsoft Office, including Excel and PowerPoint
Global regulatory compliance
Risk management
Accomplishments
- Cleared GPAT exam in the year 2016 securing a rank of 2055
- Cleared NIPER exam in the year 2016 securing a rank of 941
- Underwent Industrial training at KAPL (in all departments) for 30 days
- Underwent Industrial training at MICRO LABS (in analytical department) for 15 days
- Participated as a delegate in “Pioneering Pharmaceutical R&D to meet global challenges” (February 9th-11th, 2017)Held at Al Ameen College of Pharmacy, Bangalore
- Participated as a delegate in “Advancements and the Impacts of the Analytical & Bio analytical Techniques” (August 4th & 5th, 2017) Held at Acharya & B.M Reddy College of Pharmacy, Bangalore
- Participated as a delegate in “QbDCON - National Conference on Recent Developments, Practical and Regulatory Aspects of Quality by Design” (March 11th, 2017) Held at Krupanidhi College of Pharmacy, Bangalore
- Participated as a delegate in Poster Presentation at the 70th IPC Conference held in Amity University Campus, New Delhi NCR India from Dec 21-23, 2018
TRAINING EXPERIENCE
SEMINARS ATTENDED
Languages
5,C1,2,A2,1,A1,1,A1,1,A1,2,A2,6,C2,2,A2,3,B1,5,C1
Timeline
Senior Regulatory Consultant
Conntinuum India
05.2025 - Current
Senior Regulatory Co-Ordinator
Novartis
09.2023 - 05.2025
Regulatory Affairs Associate
Parexel International Pvt.Ltd
08.2021 - 08.2023
Regulatory Affairs Specialist
Accenture Solutions Pvt Ltd
01.2021 - 07.2021
Regulatory Affairs Associate
Cortis MedTech Pvt Ltd
09.2020 - 12.2020
Regulatory Affairs Officer
Adcock Ingram, Relicare Tech Services Private Limited
04.2019 - 08.2020
Associate Professor
Oxbridge College of Pharmacy
05.2018 - 04.2019
B. Pharm -
KLE University College of Pharmacy
Pre University - PCMB
CMR National PU College
M.Pharm - Quality Assurance
Al-Ameen College of Pharmacy
High School Diploma -
Noble Saint English School