Shivani Anand
Drug Regulatory Affairs
Ambala Cantt.,Haryana
Summary
Regulatory Affairs Professional with expertise in dossier preparation, query response compilation, and eCTD submission planning. Coordinates cross-functional teams to deliver compliant regulatory packages, including USFDA DRL and GMP inspection responses, across global markets. Supports timely product approvals by managing document review, lifecycle updates, and submission quality.
Overview
3
3
Languages
5
5
years of professional experience
Work History
Regulatory Affairs Professional
Abryl Laboratories Private Ltd.
05.2025 - Current
- Experienced regulatory affairs professional with a strong background in dossier preparation and query response compilation for the European market
- Proficient in USFDA DRL (Deficiency Response Letter) preparation, providing end-to-end support in document review and compilation for GMP inspection responses.
- Skilled in the use of electronic Common Technical Document (eCTD) format for submission planning, compilation, and lifecycle management
- Adept at coordinating with cross-functional teams to ensure timely, compliant, and high-quality regulatory submissions across global markets
- Demonstrated ability to navigate complex regulatory requirements and support successful product approvals and inspections.
Executive Officer - DRA
Venus Remedies Limited
01.2024 - 05.2025
- Responsible for filing Dossiers in South Africa and Mexico with involvement at various stages of projects by recommending regulatory strategy and conducting due-diligence.
- Planning & Co-ordination with Health authorities, clients & MA Holders of CIS countries regarding the submission, Queries & Approvals
- Major working in Variation filing for Ukraine, Prepared and maintained proper documentation for Ukraine Audit.
- Regularly follow-ups with clients & MA Holders for the progression of registration submission and approval activities and ensure the management regarding the progress in regulatory filling.
- Submission of different LCM activities like variation and renewal submission of CMC and administrative documents to respective Health authorities.
- Panchkula (Haryana)
Assistant Executive Officer - DRA
Venus Remedies Limited
04.2023 - 12.2023
- Experience in eCTD filing through Pharma ready 8.0 software for parenteral formulations.
- Review, Compilation, Drafting, validation & Submission of Generic Applications in Gulf and MENA countries.
Executive Assistant - DRA
Venus Remedies Limited
02.2022 - 03.2023
- Review and compilation of dossiers in ROW regions (CIS, ASEAN, Africa) in CTD, ACTD & country specific formats.
Drug Regulatory Affairs - Officer
Scott Edil Pharmacia Pvt. Ltd.
06.2021 - 12.2021
- Dossier preparation for Dominican Republic, Venezuela, Honduras, Yemen, Uzbekistan, Turkey.
- Chandigarh
- Ensured compliance with regulatory requirements for product registration and approval processes.
- Developed and maintained regulatory documentation, including submission files and reports.
- Collaborated with cross-functional teams to assess product changes impacting regulatory status.
Education
MBA - Pharmaceutical Management
Chitkara University
Punjab08.2026
Bachelors of Pharmacy - Pharmacy
Chitkara University
Punjab07.2021
Skills
CTD, ACTD & eCTD
Dossier preparation
Regulatory submission lifecycle management
Variation filing
PharmaREADY, Lorenz
Query response compilation
Health authority coordination
GMP inspection response support
MS Office & Libre Office
Adobe Acrobat Professional
ICH guidelines
21 CFR Part 11
CMC documentation
Accomplishments
Registered Product & Variation approvals for CIS, South Africa, Mexico, GCC & MENA Markets.
Timeline
Regulatory Affairs Professional
Abryl Laboratories Private Ltd.
05.2025 - Current
Executive Officer - DRA
Venus Remedies Limited
01.2024 - 05.2025
Assistant Executive Officer - DRA
Venus Remedies Limited
04.2023 - 12.2023
Executive Assistant - DRA
Venus Remedies Limited
02.2022 - 03.2023
Drug Regulatory Affairs - Officer
Scott Edil Pharmacia Pvt. Ltd.
06.2021 - 12.2021
MBA - Pharmaceutical Management
Chitkara University
Bachelors of Pharmacy - Pharmacy
Chitkara University