Regulatory Affairs Sr. Executive - Sunria Bioscience LLP - Ahmedabad, Gujarat
(2024-08)
- Prepare, review, and submit dossiers in ACTD/CTD/Country-specific formats for product registration in ROW markets, adhering to marketing timelines.
- Evaluate and respond to regulatory deficiencies/queries for registration and renewal processes, ensuring timely and accurate responses.
- Review technical documents (e.g., process validation, AMV, stability data, labeling, batch records, specification sheets, test methods) for compliance with regulations.
- Coordinate with HO/Plant/ADL/R&D and other departments for required documents, samples, and data.
- Check and develop artwork for registration and commercial purposes per regulatory requirements.
- Prepare regulatory submissions, product information files, COA, COPP, FSC, and product labels as per export country guidelines.
- Ensure compliance with regulatory guidelines, local requirements, and country-specific regulations for registrations and renewals.
- Assist in sample dispatches, Q&Q documents, and technical support for export registrations.
- Prepare registration dossiers for new products and variations for existing products based on market demand.
- Support audits, inspections, and provide regulatory documentation as needed.
Regulatory Affairs Executive - Medwise Overseas Pvt. Ltd. - Ahmedabad, Gujarat
(2023-01 - 2024-07)
- Prepared, reviewed, and submitted dossiers in ACTD/CTD/Country-specific formats for product registration in ROW countries per marketing department timelines.
- Evaluated and responded to regulatory deficiencies/queries for registration and renewal processes.
- Reviewed technical documents (e.g., process validation, AMV, stability, labeling, batch records, specification sheets, test methods) for regulatory compliance.
- Coordinated with HO/Plant/ADL/R&D for documents and samples required for dossiers/registrations.
- Checked and developed artwork for registration and commercial purposes as per regulatory requirements.
- Managed data related to dossiers, artworks, and records of registered products.
Regulatory Affairs Assistant - West-Coast Pharmaceuticals - Ahmedabad, Gujarat
(2020-02 - 2022-11)
- Prepared and submitted dossiers.
- Applied knowledge of scientific data for IND, NDA, and ANDA.
- Prepared and reviewed technical documents such as Certificate of Analysis, Artwork, and product permissions.
Apprenticeship - Zydus Cadila - Ahmedabad, Gujarat
(2019-08 - 2019-12)
- Worked in pharmaceutical manufacturing areas, including Compression, granulation & Coating studies and related development activities.
- Managed production-related data.
- Handled pre- and post-compression of tablets, including operation of tablet compression machines.
