Luv Wadhwani RAC

• Ensure early identification of major regulatory hurdles and issues with regard to CMC documents, regulatory and legal requirements, and coordinate for respective corrective actions. • Compile new pharmaceutical product registration dossiers, amendments, respond to the information requests, renewal dossiers and variations for Morocco. • Manage import and submission of pharmaceutical registration samples. • Lead responsible of registration process for our associate clients from India and South Korea.

• Accomplished Post Approval Life cycle changes of product registered with US-FDA (45 products). • Prepared and reviewed Annual Reports, CBE 0, CBE 30 and Prior approval supplements submission for 45 ANDAs. • Analyzed and categorized the changes for 45 ANDA’s. Planned, co-ordinate, prepared and submitted the supplements to the US-FDA. (Responsible for managing the change controls for 45 ANDA’s though TrackWise change control software).

• Compiled new pharmaceutical product registrations dossiers, amendments, responded to the information requests, product Renewals and variations for GCC countries, South Africa & All other African countries. • Reviewed/assessed and approved regulatory documents and files (specifications, manufacturing change requests, deficiency responses, registration packages and artworks). • Managed post approval changes and executed the changes as per the approval uniformly across the whole regions.

• Compiled new pharmaceutical product registrations dossiers, amendments, responded to the information requests, product Renewals and variations for EU, WHO-prequalification, CIS and ASEAN countries. • Reviewed/assessed and approved regulatory documents and files (specifications, manufacturing change requests, deficiency responses, registration packages and artworks). • Managed post approval changes and executed the changes as per the approval uniformly across the whole regions.

• Thorough knowledge of regulatory functions throughout product lifecycle for medical devices, IVDs, medicinal products (e.g., pharmaceuticals, biologics) • European regulations and guidances from the European Commission, EMA, competent authorities • Critical thinking and analytical skills

Pharmaceutics

Phamaceutical sciences