Amruta Desai

Regulatory Affairs specialist with 10 years of experience in CMC authoring, dossier preparation and lifecycle management across EU, UK and Emerging Markets for OSD products. Successfully implemented post-approval changes (Type IA/IB/II), annual reports, and global submissions with strong knowledge of eCTD Module 2 and 3. Demonstrated ability to manage regulatory submissions, handle regulatory change controls, perform gap analysis, and ensure compliance strategies.

Lead Consultant - Genpact

(2025-09)

• Executed multiple post-approval variations (Type IA, IB, II) for EU (EMA), UK (MHRA), emerging markets.
• Performed gap analysis of regulatory documents to identify non-compliance areas and recommend regulatory strategy.
• Authorized CMC documents for Module 2 and 3.
• Managed Change controls through Synaps and ensure impact assessment
• Utilized Veeva Vault RIM for document management and approval workflows.
• Collaborated with cross-functional teams and external stakeholders for project submission and regulatory compliance.
• Delivered projects within defined timelines and ensure compliance with SOP and regulatory guidelines.

Senior Officer - Brillpharma Pvt. Ltd.

(2023-06 - 2025-09)

• Successfully submitted variations (Type IA, IB & II) and Bromi submissions via MRDC and National procedures.
• Drafted CMC documents and reviewed technical documents - Module 3 and Quality Overall Summary.
• Contributed to preparation of MA Applications.
• Drafted responses to VCR and ensure timely submissions and approvals.
• Initiated of Change control procedure (through QAMS) & identified impact of changes & arrange supporting documents for submission.
• Maintained Product License Files and internal regulatory databases.

Senior Officer - MacLeods Pharmaceuticals Ltd.

(2021-12 - 2023-06)

• Prepared and submitted (Module 1-5) CTD dossiers for new and post approvals across East & West Africa Markets.
• Performed critical review of CMC documentation to support pre and post approvals
• Managed Change controls through Trackwise software and ensure impact assessment.
• Independently handled deficiency responses.
• Coordinated with cross-functional teams and maintained internal regulatory databases.

Executive - Coral Laboratories Ltd.

(2020-09 - 2021-11)

• Prepared and submitted CTD dossier submissions and Amendments to receive approval for East & French West Africa and CIS regions.
• Evaluated change controls and finalize appropriate strategy.
• Compiled and submitted post-approval supplements as and when necessary.
• Coordinated with internal teams and stakeholders for documentation.
• Prepared responses to deficiencies received from authority.
• Reviewed and release of commercial finished products.
• Managed applications Product Permission, Manufacturing License and free sale certificate.
• Supported product registration by arranging samples and documentation.

Executive - Prism Life Sciences Ltd.

(2017-07 - 2020-04)

• Prepared and submitted CTD dossiers for registration & renewal in Sri Lanka, Haiti, Guatemala, Uzbekistan, Kenya markets.
• Reviewed of the quality and analytical data as per the pharmacopoeia, specifications, MOA, batch records, Stability studies, finished product / Packaging material data to submit responses to deficiencies.
• Reviewed labeling & packaging-marketing-promotional materials & get it approved from respective authorities.
• Coordinated with internal teams to arrange finished product, working standards and reference standards.
• Reviewed supportive documents (Commercial Invoice, Packing List, FPCOAs etc.) required for dispatch of Shipment.
• Worked for Application of Trademark (India).

Officer - Flamingo Pharmaceuticals Ltd.

(2016-01 - 2017-02)

• Prepared CTD + Country specific dossiers for registration & renewal processes.
• Applied COPP, FSC, Mfg. LIC. Applications on FDA portal.
• Coordinated with QA, QC department for regulatory documents

PG Diploma - Regulatory Affairs - Institute of Pharmaceutical Management

B. Pharmacy - Pharmacy - Bharati Vidhyapeeth's College, Mumbai University