9 Job openings found

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 ...

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products. They must have excellent organizational, analytical, project management, and communication skills. They work frequently with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory affairs positions ...

    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 ...

Prepare and submit regulatory dossiers for product registrations, renewals, import licenses, and approvals. Coordinate with regulatory authorities such as Central Drugs Standard Control Organization (CDSCO). Manage regulatory compliance across India, Sri Lanka, Bangladesh, and Pakistan. Support clinical trial application submissions, amendments, and approvals. Obtain import/test licenses for clinical trial products. Work closely with clinical, supply ...

Position:         RA Executive (Khopoli) Location:        Khopoli - Raigarh Experience:     5 - 6 Years Industries:      Pharma    Responsibilities: Dossier Preparation & Submission Prepare, compile, and review CTD / ACTD / eCTD dossiers for product registration in global markets. Coordinate for ANDA, DMF, CEP, COS, and other regulatory submissions for APIs and ...

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 ...

Open Position at (Name of the company):     Designation: Head of Quality/ Regulatory (IVD)   No of requirements: 01 Nos Department/Function: Quality Location: Mombasa- Kenya Reporting to (Name & Designation): Mr. Ankur Vora (Director) No of reportees: 10-15 Nos Roles & responsibilities: 1. Quality Management System (QMS) Leadership Hands-on exposure to WHO Prequalification (PQ) processes, audits, and documentation Establish, implement, and continuously improve an integrated QMS ...

Candidate is Must [ NDT (Leval 2) ] & have knowledge of RT, PT & MT Must have knowledge of Basic Fabrications of Tank, Vessels Can Perform Stage inspection as per drawing Can prepare reports of inspection Must understand drawings & can perform stage inspection Can collect data and prepare report for ASBUILT drawing Can Handle ...

Candidate is Must [ NDT (Leval 2) ] & have knowledge of RT, PT & MT Must have knowledge of Basic Fabrications of Tank, Vessels Can Perform Stage inspection as per drawing Can prepare reports of inspection Must understand drawings & can perform stage inspection Can collect data and prepare report for ASBUILT drawing Can Handle ...