Dossier Preparation

Role & responsibilitiesExploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market.Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common...

To prepare New, Renewal dossier and variations (Site/ Formula) of MENA and CIS countries and Regulatory knowledge of Guidelines viz, ICH, FDA PICs etc.To review accuracy of executed data before submission - Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.To review of documents for adequacy and...

Job Title:Operational ManagerJob DescriptionThe Operational Manager plays a key role in ensuring the smooth operation of our business. This includes managing new dossier preparation and submission, gap analysis for completion, and compilation of dossiers in eCTD format for submission to various regulatory authorities.Additionally, the Operational Manager is...

Job Description Artwork DesignerKey Responsibilities:Develop and execute artwork activities as per project requirements.Support development for dossier submissions and variation filings.Create cutter guides in line with packaging/printing requirements.Manage shed cards with proper documentation and records.Design and develop promotional artworks.Coordinate...

Role & responsibilitiesResponsible for activities related to US/EU market.Prepare the registration dossiers as per regulatory guidelines.Submitting GCC dossiers, variations, and query responses through eCTD software.Ensure timely preparation of the agency's query responses to expedite approvals.Prepare and submit post-registration variations application,...

Job DescriptionKey Performance area:New Dossier Preparation and submissionGap analysis of dossier for completionCompilation of dossier in eCTD for submission to Various regulatory authoritiesCoordinate submission of dossiers in various countriesQuery Evaluation and SubmissionReceipt of the query letters from the respective country teamCo-ordination with the...

Job Title: Regulatory Affairs Specialist Objective:The ideal candidate will prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.Key Responsibilities:Screen and analyze documents received for product registration requests as per country-specific guidelines.Prepare, compile,...

We are seeking a detail-oriented and proactive Assistant Manager for Regulatory Affairs to join our team. The role involves preparing, reviewing and submitting regulatory documents aligned with Dossier preparation for CIS, Asian and African countries. The ideal candidate should have a strong knowledge of regulatory frameworks and experience in the...

Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global...

Job Summary:We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing...