Falguni Patel

Growth-oriented Regulatory Affairs professional with an M.Pharm specialization, seeking a challenging position in a reputed pharmaceutical organization where regulatory expertise, dossier management skills, and global compliance knowledge can contribute to organizational success and professional growth.

Executive - Regulatory Affairs - Ronak Exim Pvt. Ltd. - Vadodara

(2024-09)

• Preparation and review of dossiers as per current prescribed guidelines of respective Regulatory authorities: Cambodia, Ghana, Rwanda, Myanmar, Liberia, Sierra Leone, Haiti and Nigeria.
• Solving queries which are arise during the submission of dossiers.
• Reviewed technical documents including Specification, MOA, COA and Stability data.
• Preparation of documents like Smpc, PIL.
• Coordinated with R&D, Production, QA, and QC teams to obtain scientific data required for registrations and responses.
• Assist in the development, review and approval of product labelling and packaging materials to ensure they comply with regulatory requirements.
• Prepared documents and filed applications for COPP, Product Permission (PP), and NOC for PP.
• Knowledge of documentation and regulatory approvals for narcotic products, including obtaining required NOC.

Associate- Regulatory & Business Continuity - Sun Pharmaceutical industries Ltd. - Vadodara

(2024-03 - 2024-08)

Contractual basis

• Preparation and review of QOS as per current prescribed guideline of respective regulatory Aithorities: US, EU and Canada.
• Maintain Lifecycle Management/Post approval changes for drug product registration dossiers.
• Electronic document preparation (i.e., PDF file preparation as per CTD requirement, bookmarking, Linking and compilation).
• Review of all documents required for registration of drug products for various health authorities.
• Uploading and compilation of documents in SUBMIT PRO and PHARMA READY SOFTWARE.
• Coordinated with R&D, Production, QA, and QC teams to obtain scientific data required for registrations and responses.

Officer- RA - Mercury Laboratory Ltd. - Vadodara

(2023-06 - 2024-02)

• Prepared and reviewed dossiers for Asia (Philippines, Myanmar, Cambodia), Latin America (Chile), Africa (Ghana, Nigeria) and Nicaragua.
• Solving queries which are arise during the submission of dossier.
• Review of documents such as Specification, MOA, COA and Stability data.
• Preparation of documents like Smpc, PIL.
• Preparing draft for product permission (PP), Free sale certificate (FSC) and certificate of pharmaceutical product (COPP).
• Permission proof searching from Drug Today and IDR series.
• Coordinated with R&D, QA, QC, and Production teams for regulatory documentation.
• Assist in the development, review and approval of product labelling and packaging materials to ensure they comply with regulatory requirements.

M. Pharm. - Regulatory Affairs - Parul University, Vadodara (2023-05)

B.Pharm. - Sumandeep Vidyapeeth, Vadodara (2020-07)

H.S.C. (PCB) - Shree Saraswati Vidhyalaya, Vadodara (2016-03)

S.S.C. - Jeevan Chetna Vidhyalaya, Vadodara (2014-03)