Darshika Solanki Email & Phone Number

Melbourne, Vic, Au

Kuala Lumpur, Federal Territory Of Kuala Lumpur, Malaysia

• Managing New Marketing Authorization Applications (MAAs), Clinical Line Extensions, and HAQs for the Oncology range across all international markets, including Australia, focusing on innovative products.• Experienced in Veeva Vault (ERV) for submission management.• Strategically optimize product/market submission delivery, guiding tacticaldecisions.• Develop and maintain key relationships, align objectives, and proactively address issues and risks.• Provide expert input in Regulatory Intelligence projects like the Regulatory Requirements Repository (R3).• Foster effective communication and collaboration to streamline submission processes, accelerating filings and responses to Health Authority Queries (HAQs).• Champion best practices in international market handling within the RAM community, demonstrating excellence in complex submission delivery.• Collaborate with RAM Market Contacts to share insights from international submissions, enhancing collective knowledge.• Support iRAM initiatives to uphold regulatory consistency and achieve precise, timely submissions in alignment with established plans and metrics.

Kuala Lumpur, Federal Territory Of Kuala Lumpur, Malaysia

Handling Australia, South EastAsia, Africa, Malaysia and Singapore

Kuala Lumpur, Federal Territory Of Kuala Lumpur, Malaysia

- Registration of OTC, Natural products, Health Supplement, and cosmetics in Malaysia. - Meeting delegates of NPRA for registration related matters. - Coordinating with various contract manufacturers, company or business for products registration and other documentation.- Regulatory Planning for the new project and timely execution. - New Product Development.- Managing Database of more than 450 registered products and new development products.- Handing Registration and Life cycle management for Malaysia, Singapore, Myanmar, Cambodia, Vietnam, Srilanka, Nigeria, Uganda and Zambia.- Tech Transfer - Preparing documentation for technology transfer. Keeping all records for audit by health authorities, as and when they visit for company inspection.- Training staff to assist in preparing dossiers and answer all queries so raised by health authorities of various markets.- Coordinate with production teams along with QC/ QA teams at various locations for documentation as requested by various countries.

Mumbai, Maharashtra, India

- Reviewed and complied dossier for Australian Market (TGA).- Prepared, reviewed, and compiled Dossiers as per ACTD, CTD and eCTD format.- Prepared dossiers for ROW countries (Cambodia, Vietnam, Myanmar, Iraq, Zambia, Nigeria, Uganda, Mozambique) as per ACTD & CTD guidelines and arranging other documents required for registration of the pharmaceutical product in different countries.- Basic knowledge of the generics and branded product development process.- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance of products across the Australia and South-East Asia (SEA).- Reviewed technical documents like, Specifications, Certificate of Analysis, Test Methods, Validation Reports, Batch Records, Stability Protocols, Stability Data, Product Development Report, and Quality Overall Summary Reports.- Co‐ordinated with outside parties to obtain essential scientific data and error‐free documents required for regulatory submissions.

Mumbai

- Responsible to review dossier as per TGA/ Australian regulatory requirements.- Preparing Module 1 & RA Strategy for new product development.- Filing variation for commercialized products as per TGA regulatory requirements.- Preparation of RA table and proving information of commercialized products to unit and BD team.- Reviewing of quality documents like APQR, stability data and change control.- Handling customer queries related to commercialized products.- Coordinating with R&D, Manufacturing Units and all other stakeholders for required documents/ declarations.- Handling queries related to dossier and coordinating with other departments for the resolution.- Applying for TGA GMP Clearance for FP and API manufacturing site- Reviewing leaflet, carton and label artwork.- Updating required documents from various units.

Dahisar

- Responsible to compile the dossier format as per NAFDAC regulatory requirements.- Coordinating with R&D / manufacturing locations / Supply chain & customers for regulatory requirements / dossier compilations and compliance.- Handling queries related to dossier.- Arranging & checking art-works of products for registration- Co-ordinate with licensing department for COPP (Certificate of Pharmaceutical Products) applications- Finalization of artwork of leaflet, carton and label.- Insisting QA / QC for periodic updates in the documents

Derabassi, Punjab

- Responsible for writing and revising stability protocols in accordance with standard operating procedures (SOP’s).- To start stability studies in accordance with testing requirements and procedures to support annual requirements or as requested. Responsibilities include physically placing samples in the storage areas, initiating studies, pulling samples on scheduled pulls dates, delivery of samples to the assigned laboratory.- Trained about Maintenance of the Quality Management System (QMS) including internal audits, supplier audits, deviations, customer complaints, and document control (SOPs) and change control.- Handled audits like MHRA

M-Pharmacy, Medicinal And Pharmaceutical Chemistry

Bachelor'S Degree, Pharmacy