34 Job openings found

Job responsibilities are to Assist Regulatory manager: Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage ...

Job responsibilities : Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, CIS To manage new registration / preregistration ...

  Job responsibilities:Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD,ACTD as well as country specific format for countriesPreparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbalproducts for country specific format in countries of African Region, Cambodia, Myanmar, CISTo manage new registration / preregistration / ...

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 ...

Job responsivities are to assist Regulatory manager Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD, ACTD as well as country specific format for countries Preparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbal products for country specific format in countries of African Region, Cambodia, Myanmar, ...

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 ...

Core Job Responsibilities: Receipt, recording and reconciliation of safety information.   Update the tracker and folder after classification of ICSR by the ASR If applicable, enter the ICSR (Valid/ invalid) in OSYRIS and update the tracker with relevant RCT/LRN/AER number. Keep a track of cases received in OST, share the cases from OST to ASR ...

Primary Job Function: This position is responsible for managing Quality Systems–related initiatives within the EPD Quality Organization to ensure the supply of safe, effective, and high-quality products in compliance with regulatory and business requirements. The role also involves managing TPM QA Quality Management System (QMS) activities and related documentation. Core Job Responsibilities: Perform assigned ...

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 ...