Amrita Modak
Hyderabad
Summary
Driven regulatory affairs professional with a focus on global compliance in the pharmaceutical and biopharmaceutical sectors. Leads CTA and IND submissions for EU and US clinical trials, ensuring adherence to regulations across oncology and cell and gene therapy portfolios. Collaborates with cross-functional teams to align regulatory strategies with clinical development and long-term global objectives.
Overview
2
2
Languages
13
13
years of professional experience
Work History
Regulatory Affairs Manager
Healthark Solution LLP
12.2025 - Current
- Leading CTA/IND submissions for EU and US clinical trials, including serious breach ,unexpected event HAQ and RFIs, ensuring timely and compliant delivery.
- Managed in-house clinical studies , driving regulatory strategy for CAR-T cell therapy and execution for the dedicated client Miltenyi Biomedicine.
- Coordinated with Miltenyi global team to establish regulatory strategy for PIP compliance activities in Europe, enhancing alignment across stakeholders.
- Executed CTA/IND amendment submissions for cell and gene therapy products within oncology portfolio for German-based Miltenyi Biomedicine.
Regulatory Affairs Manager
AstraZeneca India Pharma limited
BANGALORE
09.2024 - 11.2025
- Led CTA/IND submissions for EU and US clinical trials, including HAQ and RFIs, ensuring timely and compliant delivery. Managed in-house and CRO-led clinical studies and medical device IVDR studies, driving regulatory strategy and execution.
- Reviewed and prepared submission components for EU CTR (Regulation 536/2014) for in-house and CRO-led studies, ensuring successful IND applications for new indications and amendments, including protocol updates, IB submissions, DSUR, SUSAR, and post-approval lifecycle management (PBRER, CMC and non CMC variations).
- Applied detailed knowledge of EU IVDR (2017/746), MDR (2017/745), UK IVD/MDR 2002, and Swissmedic Clino-MD regulations for compliance in diagnostic and medical device studies.Executed EU-IVDR submissions, including Q-submissions and Significant Risk determinations for US IVD. Maintained compliance by keeping ERV (Veeva Vault) dashboards and internal tools (e.g., Power BI) up to date.
- Demonstrated deep expertise in Oncology (Breast, Lung) and Cell & Gene Therapy portfolios, managing Phase II and Phase III clinical trials and IVD studies.
- Submitted Premarket application and 510K submission of Medical device.
- Leveraged AI tools (Copilot, ChatGPT) and analytics platforms to enhance regulatory processes and reporting efficiency.
- Catalyse Award:- We Play Together To Win for effective Management of CRO led study (Critical Phase-I and Phase-III)under Breast and Lung portfolio.
Regulatory Affairs Specialist 1
Glaxo Smith India Pvt Ltd
12.2022 - 08.2024
- Successfully submitted IND applications for new indications and amendments, including protocol updates, IB submissions, DSUR, SUSAR.
- Managed CTA submissions across EEA, ROW, and Health Canada, ensuring compliance with regional regulatory requirements and facilitating timely study progression.
- Specialised in CTD and CTIS submission processes, including initial/new-file submissions, substantial amendments, and CSR & EOT notifications.
- Reviewed and prepared submission components for EU CTR (Regulation 536/2014) for both in-house and CRO-led studies.
- Drafted cover letters, substantial amendment forms, and EudraCT forms for CTD-based clinical trials, contributing to successful regulatory reviews.
- Experienced in Regulatory Vault and Clinical Operations systems for efficient document and submission management.
- Awarded Bronze Award for effective management of initial CTA submissions to EU and ROW countries.
- Received E-card appreciation from stakeholders for effective submission management and fostering collaboration across teams.
Senior Regulatory Affairs Associate
IQVIA Biotech RDS India Pvt Ltd
BANGALORE
02.2021 - 11.2022
- Prepared initial CTA package (core cover letter, Annex-1 & LOA) customised to meet country-specific requirements for Belgium, Greece, Ireland, Poland & Spain, ensuring compliance with organisational SOP for high-quality submissions, amendments & notifications.
- Additionally, prepared the EC submission package, including country-specific cover letters and necessary documents such as site suitability, PI's CV, GCP certificate, IB protocol, and ICF SmPC. Submitted the initial CTA package for Belgium and Ireland through CESP.
- Prepared and submitted global EOT notification package to Belgium, Ireland, Germany, UK, Italy, Spain & Denmark, and also prepared site closure and start of trial notifications for the study.
- Prepared notification package for submission to Hungary, Poland, Germany, and Czech Republic.
- Reviewed the QC package on time for the internal team.
- Filling all relevant submission to eTMF & Info Start in timely manner to comply with the GCP & Global EU CTIS/ EU Directives.
- Participated in daily kick-off meetings with internal and external stakeholders to update project progress and ensure alignment.
- Submission time sheet & other necessary tool for business compliance.
Senior Research Associate
Syngene International ltd
03.2018 - 02.2021
- Detailed experience in writing CMC module 3.2 S2 and S3 section. Reviewing CMC documents. S-BLA and S-NDA supplement to FDA.
- Submitted CMC variation Type-II and Type IA variation to EU markets. Experience in submitting Type IB and Type-II variation in EU, NDA, BLA submission.
- Provided regulatory support to internal stakeholders for EU approval process, preparing essential source documents for variation submission including clinical trial regulations, investigators' brochures, NDA, ANDA, BLA, MAA, and GMP guidelines to ensure adherence to regulatory standards.
- Discussed and supported queries related to regulatory affairs, completing allocated tasks within timelines to facilitate compliance and project progression.
- Generated stable cell lines and transiently expressed biopharmaceutical drug substances, compiling data and updating electronic lab notebook daily while preparing presentations for routine projects to ensure clear communication of findings.
- Basic understanding of eCTD/ CTD / ACTD Basic understanding on Global regulatory authorities of Pharma & Health care Industry like- ICH EMA, TGA, CDSCO etc.
Associate
Dr Reddy's Laboratory Ltd.
12.2015 - 03.2018
- Detailed experience in writing CMC module 3.2 S2 and S3 section. Reviewing CMC documents S-BLA and S-NDA supplement to FDA.
- Conducted activities in accordance with relevant SOPs, ICH guidelines, and schedule M, while maintaining and reviewing batch records to ensure cGMP compliance and proper documentation.
- Prepared working cell bank from master cell bank, characterised cell banking as per ICH Q5 guideline, and optimised process parameters during seed expansion and scale-up of biopharmaceutical drug substances, including monoclonal antibodies and recombinant proteins.
- Finalised process orders and tracked production accurately through SAP system, facilitating efficient production workflows.
- Contemporaneous entry of commercial & clinical batch data by using relevant software like process pad. Reviewing of batch production record etc.
Senior Research Associate
Natural Remedies Pvt. Ltd.
01.2014 - 11.2015
- Executed responsibilities as Test Item Control Officer (TICO) at GLP facility, ensuring compliance with GLP documentation standards.
- Performed cell culture maintenance (seeding, sub-culturing, cryopreservation) for various mammalian cell lines including CHOK1, HepG2, MCF7, ensuring optimal growth conditions.
- Executed aseptic techniques for animal cell culture to ensure contamination-free environments.
- Screened new herbal entities for pharmacological activity through biochemical assays and evaluated cytotoxic effects using MTT assay across different cell lines.
- Trained on Upstream process, Sartorius 5 Liter fermenter operation.
- Downstream processing (Filtration &different chromatographic technique.)
- Completed BCIL training in Biozeen on Biopharmaceutical process in Bangalore in the year 2013.
Education
Master of Science (M.Sc.) - Biotechnology
Jadavpur University
Kolkata, India01-2012
Bachelor of Science (B.Sc.) - Biochemistry
University of Calcutta
Kolkata, India01-2010
Higher Secondary Education (Science) - Science
West Bengal Council of Higher Secondary Education (WBCHSE)
Kolkata, WB01-2007
Secondary Education -
West Bengal Board of Secondary Education (WBBSE)
Kolkata, WB01-2005
Skills
- CTA submissions
- IND filings
- EU CTR
- IVDR compliance
- CTIS administration
- Regulatory strategy
- Clinical trial management
- Clinical trial oversight
- Stakeholder coordination
- Good clinical practice
- Veeva Vault
LANGUAGES
English C2 - Proficiency
German A2 - Elementary
PROFESSIONAL TRAINING
- BCIL training in Biozeen on Biopharmaceutical process, Bangalore
- Jan 2013 - Jan 2013
- BCIL training in Biozeen on Biopharmaceutical process, Biozeen
- Lean six sigma white belt certification, Syngene International
- Biotech Consortium Industrial Training Program
KEY HIGHLIGHTS
- Managing global regulatory submissions and lifecycle management: Proven success
- Knowledge of EU IVDR (2017/746), UK MDR 2002, Swissmedic, and US FDA medical device regulations: Strong
- Proficiency in AI tools (Copilot, ChatGPT) and data visualization platforms (Power BI): Proficient
- Leadership, attention to detail, and effective stakeholder communication: Recognized
Timeline
Regulatory Affairs Manager
Healthark Solution LLP
12.2025 - Current
Regulatory Affairs Manager
AstraZeneca India Pharma limited
09.2024 - 11.2025
Regulatory Affairs Specialist 1
Glaxo Smith India Pvt Ltd
12.2022 - 08.2024
Senior Regulatory Affairs Associate
IQVIA Biotech RDS India Pvt Ltd
02.2021 - 11.2022
Senior Research Associate
Syngene International ltd
03.2018 - 02.2021
Associate
Dr Reddy's Laboratory Ltd.
12.2015 - 03.2018
Senior Research Associate
Natural Remedies Pvt. Ltd.
01.2014 - 11.2015
Master of Science (M.Sc.) - Biotechnology
Jadavpur University
Bachelor of Science (B.Sc.) - Biochemistry
University of Calcutta
Higher Secondary Education (Science) - Science
West Bengal Council of Higher Secondary Education (WBCHSE)
Secondary Education -
West Bengal Board of Secondary Education (WBBSE)