42 Job openings found

Duties and Responsibilities : Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...

  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...

  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...

  Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority. Well versed with the guidelines of ICH and other regulatory. Preparation of documents for license application. Preparation of documents for COPP, FSC and other legal documents including product permission Preparation of registration documents as per ACTD , CTD ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...

The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information sought etc. Such regulatory offices include DGCA, Various Ministries, AAI etc. The official under the role w The Regulatory affairs team supports all the departments within the organization towards all regulatory requirements including approvals, reports, information ...

Experience to prepare and review the documentation required for the ISO 9001:2015, EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745, IMDR 2017. Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s, Change Control, Deviation, CAPA, Incident, and Customer complaint, Management Review Meeting, pdate Harmonized Standards, ...

Position:        Sr. Executive - Production & Project Location:        Ahmedabad Experience:    8 - 10 years Industries:     Pharma Job Responsibilities:         Operational Management Preparation of URS, ensure equipment qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Oversee operations, ensuring efficient and compliant production. Manage project & production schedules, production planning, ...

Job Location : Mahape, Nearest Station Ghansoli (Navi Mumbai)   Look for people from Navi Mumbai or Mumbai Only   Only Female Candidates required   Qualification : B.Pharm / M.pharm   Experience : 1yr – 3yr   Salary : 1.42lpa – 2 .80lpa     Profile : Experience in preparing Dossiers in CTD, ACTD, Country Specific Dossiers.   Countries : ROW and Latum   Job Description: Dossier Preparation along ...

Position:        Head Production - NPD Location:       Ahmedabad Experience:   22 - 25 years Industries:     Pharma   Primary Responsibilities: Strategic Planning: Develop and implement new product development strategies aligned with company goals. Project Portfolio Management: Oversee the new product development project portfolio, prioritizing projects and allocating resources. Cross-Functional Leadership: Lead cross-functional teams, including R&D, Manufacturing, Quality, and Regulatory Affairs. Product Conceptualization: ...