35 Job openings found

Job Description:  Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. ? Preparation, Compilation & Review of Registration documents that include Administrative & Technical. ? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ...

  Key Responsibilities: Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations. Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance. Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals. Ensure dossiers and product ...

Job profile. 1.      Dossier preparation and filling for product registration in International Regulatory bodies. 2.      Query replies to International regulatory authority for the dossier for product registration. 3.      Documents follow up with Production,QA and QC dept required for Dossier preparation. 4.      Regulatory Samples follow up for the product registration along with dossiers filling. 5.      Product finalization with clients as per ...

    Regulatory Affairs Officer (RA) Qualification: B.Pharm/ M.Pharm Experience: Minimum 3 years in regulatory affairs for the ROW (Rest of the World) market, with a total of 3 to 5 years of experience. Job Description: Preparing dossiers as per country-specific guidelines. Compiling and reviewing documents. Coordinating with QA for documentation. Addressing queries raised by respective countries' FDA. Bond: 18-month ...

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 ...

Designation: Associate - AS&T (Analytical Science & Technology) Location: Baddi Qualification: Any Working days: 6 Days Working time: 08:30 am to 05:00 pm Experience: 10+ Years Salary: Best in industry Note: This role will be on payroll of Talisman HR Solutions   Job Profile: Support Established Products Operations (EPO) technical functions- India region for India market.  Job Responsibilities: Review the technical dossiers for availability of ...

The following is a general job description for a Documentation Audit Engineer or Quality Control(QC) Documentation Auditor specializing in Transmission Tower Fabrication. Documentation Audit Engineer / QC Documentation Auditor (Transmission Tower Fabrication)Job SummaryThe Documentation Audit Engineer is responsible for independently planning, executing, andreporting on audits of the quality control and project ...

Position:          Regulatory Manager Location:         Mumbai Experience:      5 - 8 Years Industries:       Chemical Responsibilities. Global Product Registration & Dossier Management Lead the full registration lifecycle (pre-market research, submission, renewal) for all target export countries. Compile regulatory dossiers, including 5-batch analysis and efficacy data, ensuring strict adherence to national formats. Serve ...

Key Responsibilities:Project Planning & ControlsOwn the site execution plan, micro‑schedule, and S‑curve; develop and track weekly look‑ahead plans.Establish and run daily/weekly progress review meetings (internal + contractors); publish DPR/WPR/MPR and executive dashboards.Drive critical path items, interface management (civil–mechanical, electrical–instrumentation), and change control.Budget tracking: RA bill verification, BOQ/BOM reconciliation, contractor productivity, ...

Position:         RA Trainee(Khopoli) Location:        Khopoli - Raigarh Experience:     0 - 1 Years Industries:      Pharma    Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production ...