S. Rajesh Kumar Email & Phone Number

Tamil Nadu, India

Chennai Area, India

As an Assistant Manager – Worldwide Regulatory Operations, playing a vital role in Centralized Data Management & Regulatory compliance related to navigation, format, and document structure. I am involved in providing direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions. Additionally, perform hands-on daily submission compilation and publishing activities associated with… Show more As an Assistant Manager – Worldwide Regulatory Operations, playing a vital role in Centralized Data Management & Regulatory compliance related to navigation, format, and document structure. I am involved in providing direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions. Additionally, perform hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports. I am responsible for the overall quality of the assigned documents and dossiers which must comply with all internal best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities Show less

Chennai Area, India

As a Senior Executive – Worldwide Regulatory Operations, playing a vital role as a Subject Matter Expert (SME). I am responsible for regulatory compliance related to navigation, format, and document structure. I am involved in providing direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions. Additionally, perform hands-on daily submission compilation and publishing activities… Show more As a Senior Executive – Worldwide Regulatory Operations, playing a vital role as a Subject Matter Expert (SME). I am responsible for regulatory compliance related to navigation, format, and document structure. I am involved in providing direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions. Additionally, perform hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports. I am responsible for the overall quality of the assigned documents and dossiers which must comply with all internal best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities Show less

Chennai Area, India

As an Executive – Worldwide Regulatory Operations, Managed eCTD Submission for all markets (US, EU, ROW and GCC Countries).Experienced in publishing various Regulatory dossiers in various formats like eCTD, Hybrid, Nees and Paper submission.Handled various submission types which includes Original submission, Supplements, Amendments, Variations, Annual Reports, PSURs, DMF.Hands on experience in handling various tools like eCTD Xpress and Trackwise.Responsible for archiving the… Show more As an Executive – Worldwide Regulatory Operations, Managed eCTD Submission for all markets (US, EU, ROW and GCC Countries).Experienced in publishing various Regulatory dossiers in various formats like eCTD, Hybrid, Nees and Paper submission.Handled various submission types which includes Original submission, Supplements, Amendments, Variations, Annual Reports, PSURs, DMF.Hands on experience in handling various tools like eCTD Xpress and Trackwise.Responsible for archiving the regulatory dossiers.Preparation of APQR Summaries.Involve in the migration activities from hospira to Pfizer system. Show less

Chennai Area, India

As an Executive - Regulatory Affairs, involved in providing support to publish the global dossiers with quality. Keyed out the technical review of components for eCTD submissions ensuring they are technically compliant. Applying an appropriate level of necessary navigational aids (e.g. inter-hyperlinks, bookmarks), and validating the output with appropriate tools.

As a Regulatory Associate, I have successfully handled various submission types, entailing Original Submission, Supplements (Labeling, CBE-0, CBE-30 & PAS), Amendments (IR Response, Complete Response, etc.) Variations, Annual Reports, PSURs & DMF. Worked on the archival process for both word documents as well as for final output. Carried out formatting of documents which is submission ready. Gained expertise in NeeS submissions for EU region through MRP/DCP and NP procedures.

As an Executive - Regulatory Affairs, involved in planning and execution of drug product registration process for various countries.Review of documents and compilation of quality dossier.Handling of technical and non- technical queries raised by regulatory authorities and giving response in time.Maintaining data base of technical information, products registered, re-registration deadlines.

M.Pharmacy

B. Bharmacy