SWATI CHAVAN
Bangalore
Summary
Dynamic regulatory affairs executive with proven success at Adcock Ingrams-Relicare Tech Pvt. Ltd, specializing in eCTD submissions and lifecycle management. Expert in scientific writing and regulatory compliance, adept at leading cross-functional teams to secure approvals from global agencies, ensuring high-quality submissions that meet stringent timelines.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Executive
Adcock Ingrams- Relicare Tech Pvt. Ltd
11.2024 - Current
- Expert in regulatory affairs with a strong focus on CMC documentation and lifecycle management (LCM). Proficient in creating, reviewing, and managing technical and regulatory documents such as CEPs, CPQs, DMFs, BMRs, and BPRs, ensuring compliance with global standards.
- Drafting of the eCTD sections for regulated market such Europe, SAHPRA, USA, Canada, Brazil etc. for biological products and/or synthetic peptides.
- Adept at compiling comprehensive CTD/eCTD dossiers (Modules 1–5) for various regulatory submissions, including NPDs, variations, and renewals, pre- & and post-registration query addressing, while adhering to ICH and country-specific guidelines.
- Successfully led end-to-end submission processes for international regulatory bodies like EMA, SAHPRA, and USFDA, securing approvals and maintaining compliance.
- Skilled in designing regulatory strategies for product registrations and lifecycle management, coordinating with cross-functional teams to deliver high-quality submissions within strict timelines.
- Proven expertise in advanced publishing tools, such as Lorenz eValidator and DocuBridge, ensuring technical accuracy and integrity in electronic submissions.
- Demonstrated ability to manage regulatory discussions, evaluate change controls, and prepare strategic documents such as Regulatory Strategy Documents (RSD) and APQR summaries.
Senior Research Associate
Syngene International Ltd.
05.2022 - 10.2024
- Specialized in analytical techniques: CE, icIEF, AUC, HPLC, and impurity profiling (HCD, HCP, rProA).
- Coordinated regulatory dossier submissions for USFDA, EMA, and other agencies.
- Developed critical documents: QTPP, MDR, MQP, Risk Assessments, and Stability Data.
- Implemented QMS tools (Trackwise, EDMS) for electronic documentation and compliance.
- Guided cross-functional teams to achieve project deliverables within TAT.
Junior Research Associate
Hetero Biopharma Ltd.
12.2020 - 11.2021
- Conducted bio analytical assessments (ADA, Nab, PK) and supported vaccine analytical projects.
- Developed and validated methods per ICH-Q2 (R1) guidelines.
- Managed technical documentation, including SOPs, MDRs, and MQRs.
- Performed impurity profiling and residual DNA analysis for clinical samples.
Education
M.Pharmacy - Pharmaceutical Sciences
RCPIPER
Shirpur01.2020
B.Pharmacy - Pharmaceutical Sciences
P.S.G.V.P Mandal college of pharmacy
Shahada01.2018
Skills
- Scientific Writing
- MS Office
- Multitasking
- Regulatory compliance
- Biologics / Biosimilar
- eCTD publishing
- Risk assessment
- Stakeholder engagement
- CTD/eCTD submissions
- Analytical qualification and validation
Certification
- Regulatory Affairs Certification (RAC), North Maharashtra University, Jalgaon, 08/01/19, 07/31/20
- Biologics Safety and Medical Writing, Udemy, 09/01/22, 09/30/22
- Drug Regulatory Affairs, Rainbow Clinical Research and Management, 10/01/23, 10/31/23
Languages
- English
- Hindi
- Marathi
Disclaimer
I hereby declare that the details and information provided above are accurate and true to the best of my knowledge.
Timeline
Executive
Adcock Ingrams- Relicare Tech Pvt. Ltd
11.2024 - Current
Senior Research Associate
Syngene International Ltd.
05.2022 - 10.2024
Junior Research Associate
Hetero Biopharma Ltd.
12.2020 - 11.2021
M.Pharmacy - Pharmaceutical Sciences
RCPIPER
B.Pharmacy - Pharmaceutical Sciences
P.S.G.V.P Mandal college of pharmacy
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