34 Job openings found

Job description -   To perform effective gap analysis between sender & receiving site in process & equipment and to provide solution for smooth technology transfer. To prepare Master formula record & Technology transfer protocol for products identified for transfer. To Review receiving site’s draft documents pertaining to manufacturing, process validations & analysis of ...

Project Folder Setup: You will be responsible for initiating and organizing project folders in accordance with company's  documentation standards. • Dossier Compilation (in collaboration with the Database Team): You will work closely with the Database (DB) team to compile project dossiers. This involves gathering, organizing, and validating data from various sources to ...

  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 ...

Title: Analyst, Contract Management   Experience: 5 years of work experience as a Contract Management. Experience working in construction sites or engineering projects. Project Management experience is a desirable qualification.   Working: 48 hours per week Salary: Basic- SR- 6000 to 7000, TA- 10%, Housing Allowance: 16.66% of Basic Salary. Duration: Long Term Location: Dammam, Saudi Arabia Educational Qualification:   Bachelor’s Degree or Diploma in Project Management/Engineering   Job Requirements: Coordinate ...

  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 ...

KEY RESPONSIBILITES: • Team Handling.• Assist/guide team member to enable them for below: Ensure timely compilation & submission with best quality of Dossiers, (Asia, Africa, CIS and LATAM) and maintain proper records of the same.• Handling queries for Asia, Africa, CIS and LATAM.• Query tracker updates on weekly basis.• Timely response ...

Position:         Sr.- Executive /Executive-Process Location:         Cuddalore -Tamil Nadu Experience:      4- 6 Years Industries:       Chemical Responsibilities: Knowledge of process related standards Design, run, test and upgrade systems and processes work between R&D and plant – developing dossier, pilots, equipment defining Create, configure and develop industrial processes Appraise, measure and analyse processes Complete process ...

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 ...