Sujit Kumar Nath Email & Phone Number

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka

• Responsible for compilation of technical documents (Dossiers) for Variations, Renewal, Withdrawn & Marketing authorization application for EU & global submission. Also drafting the cover letters, application forms for preparation of Module-1 for global submissions. • Collaborate with Client for generation, review and finalization of Regulatory submission documents & Implement strategies to ensure timely submission.• Create documents using RIM Vault & managing the eRIMS information of… Show more • Responsible for compilation of technical documents (Dossiers) for Variations, Renewal, Withdrawn & Marketing authorization application for EU & global submission. Also drafting the cover letters, application forms for preparation of Module-1 for global submissions. • Collaborate with Client for generation, review and finalization of Regulatory submission documents & Implement strategies to ensure timely submission.• Create documents using RIM Vault & managing the eRIMS information of the products to reflect the latest approved information.• To connect with different stakeholders and partners and establish strong working relationships. Show less

Bangalore

• Preparation, review and submission of the dossiers as per CTD Format for US & Global market. • Involved in the post approval management such as CMC Variations , Annual report , Renewals and change control assessment.•Responsible for the query response and expedite the response to regulatory authorities for timely submission.• To coordinate with the various cross functional departments and review of regulatory submission documents and ensure the documentation complies with… Show more • Preparation, review and submission of the dossiers as per CTD Format for US & Global market. • Involved in the post approval management such as CMC Variations , Annual report , Renewals and change control assessment.•Responsible for the query response and expedite the response to regulatory authorities for timely submission.• To coordinate with the various cross functional departments and review of regulatory submission documents and ensure the documentation complies with regulation for international submission in a timely manner. Show less

India

• Preparation , review and submission of the dossiers as per CTD Format for US & Global market.• Actively involved in deficiencies response , CMC Variations throughout the product lifecycle.• To coordinate with the various cross functional departments and review of regulatory submission documents.

India

• Prepare and review of CTD dossier and ensuring the sourcing of material , manufacturing and testing is carried out as per the dossier and maintaining dossiers and registration documents for all registered products.• Follow Up and tracking and submit documents for deficiencies response , CMC Variations and queries raised by regulatory authorities during the registration process.• Evaluation of change control to assess the regulatory impact.• Review of Technical aspects of the… Show more • Prepare and review of CTD dossier and ensuring the sourcing of material , manufacturing and testing is carried out as per the dossier and maintaining dossiers and registration documents for all registered products.• Follow Up and tracking and submit documents for deficiencies response , CMC Variations and queries raised by regulatory authorities during the registration process.• Evaluation of change control to assess the regulatory impact.• Review of Technical aspects of the contracts or Technical agreements, Marketing Authorization, Export orders for compliance with regulatory details and coordinate for necessary approval for updation .• Review and approved of documents required for regulatory agencies such as - Master Formulation Record (MFR), Master Packaging Record (MPR), Batch Manufacturing Record (BMR), Stability protocol, Process validation protocol- report, Product Development Report (PDR), analytical report and Product quality review (PQR). Show less