23 Job openings found

Job Summary The Regulatory Affairs Manager is responsible for ensuring that products are in compliance with all applicable regulations and laws. This includes developing regulatory strategies, preparing regulatory submissions. The Manager also provides guidance to the cross functional and Area regulatory affairs team and ensures that all regulatory activities are aligned ...

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, ...

Description : Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance: Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with production teams to establish quality control ...

    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 ...

Experience: 10+ years of experience including team handling experience in similar domain Location: Ahmedabad, Gujarat   Summary of Profile specifications:   Incumbent should have sound knowledge of domestic regulatory functions with ref to DBT-RCGM, CDSCO and state FDA regulations.  He/she should be a seasoned professional with leadership qualities, have knowledge about NDCT rules, Biosimilar guidelines, cGMP ...

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 ...

  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 / ...

Designation: Trainee – Regulatory Affairs Location: Kurla  Qualification: Any Graduate Working days: Mon to Fri Working time: 09:00 am to 05:00 pm Experience: 0-2 Years Contract Duration: 1 Year Salary: Best in industry Note: This role will be on payroll of Talisman HR Solutions Work Responsibility: Assist in preparing and submitting dossiers. Coordinate with internal teams to collect required data. Maintain regulatory records ...

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 ...

Job description for API Regulatory: Preparation, review and submission of Drug Master Files/CEP in eCTD format for the regions US, EU through ESG and CESP. Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates). Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data ...