Sumit Dalwani Email & Phone Number

- Strategic Bid Management: Utilize your expertise to proficiently handle large-scale Request for Proposal (RFP) processes across diverse geographical regions, showcasing comprehensive knowledge of Regulatory Affairs.- Demonstrate exceptional project management skills as you effectively manage major and long-term RFP/RFI/proposal projects, ensuring successful outcomes.- Collaborate with clients to understand their regulatory affairs challenges and requirements.- Conduct in-depth consultations to identify areas of improvement and potential solutions.- Develop innovative and effective regulatory solutions to address client needs.- Monitor and review progress against the bid plan, taking proactive measures to address deviations and ensure adherence to timelines- Provide expertise in global regulatory affairs and ensure solutions are adaptable to various regulatory environments.- Guide regulatory compliance to internal teams.- Create comprehensive documentation for regulatory solutions, including user manuals and standard operating procedures.- Case Study Collaboration: Collaborate with Delivery Managers to develop compelling case studies for internal knowledge sharing and potential external publication.- Collaborate with the sales and business development teams to provide pricing structures for regulatory solutions.- Negotiate contracts with clients, ensuring terms are mutually beneficial and compliant with company policies.- Manage contract renewals and modifications, addressing client needs and ensuring ongoing satisfaction.

Ahmedabad, Gujarat, India

- Preparation, compilation, review and submission of complex generic dossiers. - To develop effective strategies for complex peptides to gain regulatory approval. - Diverse experience on compilation of dossier for Ophthalmic, Injectables, Vial, PFS & Lyo etc. - Submission of Development meetings, Pre-ANDA meetings, PFC, CGT, and CC, for drug device combination products. - Technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverable i.e. sterility assurance package.- Cross functional alignment with all stakeholders (including external CMO).- Provide support to internal, stakeholder like R&D and plant for development. - Maintains current knowledge of regulations and that affect products and industry.

Bengaluru, Karnataka, India

- Preparation, compilation, review and submission of Dossiers for global markets such as US, Europe and China, etc. - Evaluation of documents to ensure and categorize the regulatory post approval compliance using guidelines, in-house policies and procedures upon review of Change Control Documentation. - Ensuring timely submission of Query responses.- Assess the appropriate regulatory reporting mechanism using FDA regulations, guidance documents and in-house policies and procedures upon review of Change Control Documentation.- Provide a critical detailed review of technical documentation including product labeling, product distribution reports, analytical procedures, product specifications, manufacturing batch records, in-process specifications, etc. prior to submission.- Maintain current knowledge of regulations and guidance’s pertaining to changes to approved regulatory applications by utilizing the agency website and attendance at conferences.- Maintain departmental regulatory files/database and chronologies in good order.

Govandi, Mumbai

- Preparation and compilation of DMF/Dossiers for Difference Regulatory Agencies like US and Europe- Preparation and compilation of amendments and annual reports for regulatory submission.- Preparation of Deficiency Response for the queries received from Regulatory Agencies and customers. - Expert with submission platforms i.e. ESG & CESP.- Query response and life cycle management and performing GAP Analysis - Preparation, review and submission of annual and Intermediate Notification, Minor and Major Revisions - Preparation of product dossier (PDS)

Mumbai Area, India

- Analytical Method development and validation- Stability studies and interpretation- Force degradation studies with Mass balance- Handled Equipment's : UV, IR, Mass, Particle sizer, HPLC, DSC, TGA etc.

Master Of Business Administration - Mba, Marketing/Marketing Management, General, First Class

M.Pharm, Pharmaceutical Analysis, First Class

Project Title- "Modern approaches in the quantitative analysis of drug using sophisticated instrument".

Bachelor’S Degree, Pharmacy, First Class With Distinction

Activities and Societies: NSSLearned Pharmacy