Manage and execute planning, compilation and dispatch of submissions to Health Authorities during the application lifecycle.Create and update submission packages and Submission Content Plans for submissions to Health Authorities.Create and update records in Regulatory Information Management system and ensure submissions are documented properly including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM.Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format.Perform quality checks, validate eCTD output, and submit eCTDs through supported HA gateway.Collaborate with submission management and publishing vendors, resolve or coordinate any queries, and perform spot checks on output.Functional oversight of vendors for submission management and publishing.Crisis intervention in case of vendor issues to avoid impact on quality or project timelines.Key contact for eCTD and Publishing expertise.Act as power-user for submission applications (Veeva Vault RIM).Author cover letter and application forms in close cooperation with the License Manager or Regulatory Lead.Monitor compliance with submission standards and submission process (internal & external).

eCTD Life Cycle Management .CMC compilation, Docubridge, Lorenz ,Validation and Regulatory document management system.• Control submission content, being accountable for the receipt and workflow completion of all submission components, resulting in a high quality final product.• Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner.• Develop milestones and timelines, to relay these objectives to the team, and to ensure that the team is successful in obtaining these goals.• Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the submission.• Regular communication with the client, including, but not limited to, face-to-face meetings, presentations, telephone, email, and conference call interaction.• Ensure that Specific Project Specifications, if they exist, are strictly adhered to throughout the lifecycle of the submission.• Keep the project within budget by properly managing resources.• Verify and approve project time.• Be prepared to deploy without extended notice.• Perform project management in the absence of the Project Manager.• Conduct performance reviews of publishing team.• Dossier Compilation (ANDA and IND)• CMC, DMF, GMP, CTD, eCTD.• Annual Update DMF(USDMF,CDMF,EDMF)• Regulatory affairs administration Support • Review of Master Documents• Regulatory affairs Data Base Management• eCTD, Nees Submission to US & Europe

• Control submission content, being accountable for the receipt and workflow completion of all submission components, resulting in a high quality final product.• Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner.• Develop milestones and timelines, to relay these objectives to the team, and to ensure that the team is successful in obtaining these goals.• Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the submission.• Regular communication with the client, including, but not limited to, face-to-face meetings, presentations, telephone, email, and conference call interaction.• Ensure that Specific Project Specifications, if they exist, are strictly adhered to throughout the lifecycle of the submission.• Keep the project within budget by properly managing resources.• Verify and approve project time.• Be prepared to deploy without extended notice.• Perform project management in the absence of the Project Manager.• Conduct performance reviews of publishing team.• Dossier Compilation (ANDA and IND)• CMC, DMF, GMP, CTD, eCTD.• Annual Update DMF(USDMF,CDMF,EDMF)• Regulatory affairs administration Support • Review of Master Documents• Regulatory affairs Data Base Management• eCTD, Nees Submission to US & Europe

• Generating copies of registration documents for submission to different agencies and Authority OF USFDA and MHRA, TPD,EDQM• Preparation of letter of access based on the requirements of Marketing• Preparation of Technical package Send to the Customer• Customer query Response regarding deficiency in DMF• Document compilation For USA and Europe Market As per ICH Q7 Guideline in CTD Format• Administration supporting work related to Regulatory affairs Department• Annual update of USDMF and biannual update of Canada DMF Documents• Dossier Compilation For US & European Market and Submission to Authority• Works effectively within a team environment to author and compile regulatory authority submissions for medicinal products globally. • Perform advanced document management tasks including file transfer, storage, tracking and archival.• Understanding differences between regulatory agencies and regional preferences for product development, clinical trials and regulatory information management (RIM).• Provide basic paper and electronic publishing services including document preparation, scanning, word formatting, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumation, pagination, and formatting of reports

Handling of Insight Manager®, eDossier®, Adobe Acrobat Pro, FirstDoc®. ISI Tool Box.Generating copies of registration documents for submission to different agencies and Authorityof USFDA and MHRA, TPD, EDQM.Submission Coordination for Regulated marketsCompile and check pharmaceutical quality documentation (Module 3, QOS, IMPD, ASMF etc.) for national and international marketsPrepare Gap Analyses of pharmaceutical quality dossiers in the context of marketing authorization projects, Due DiligenceSet up responses to deficiency letters from authoritiesSupervise development projects and marketing authorization procedures with regard to the pharmaceutical quality documentationCompile and review Product Quality Reviews (PQRs)Coordinate and perform CEP proceduresCoordinate and perform Life Cycle Management processes with regard to the pharmaceutical quality documentation (change control procedures, prepare and submit variations, site transfers etc. with regard to strategy and content)

Handling of Insight Manager®, eDossier®, Adobe Acrobat Pro, FirstDoc®. ISI Tool Box.Generating copies of registration documents for submission to different agencies and Authorityof USFDA and MHRA, TPD, EDQM.Submission Coordination for Regulated markets.Preparation of letter of access based on the requirements of MarketingPreparation of Technical package Send to the CustomerCustomer query Response regarding deficiency in DMFDocument compilation For USA and Europe Market As per ICH Q7 Guideline in CTD FormatAdministration supporting work related to Regulatory affairs DepartmentAnnual update of USDMF and biannual update of Canada DMF DocumentsDossier Compilation For US & European Market and Submission to AuthorityWorks effectively within a team environment to author and compile regulatory authoritysubmissions for medicinal products globally.Provide basic paper and electronic publishing services including document preparation,scanning, word formatting, rendering, bookmarking, hyperlinking, compilation, table ofcontents creation, volumation, pagination, and formatting of reports.