74 Job openings found

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 ...

  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 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 & ...

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 ...

1. Good credincial 2. Passout 2024 or 20253. Local candidate only4. Salary starting CTC 15K After a six month CTC will be 17K and finally after completion of 01 year he will be Asst. Engineer and CTC will be 19K.         An Electrical & Instrumentation (E&I) Engineer is responsible for designing, developing, ...

Job Description To carry out all experiments and routine work To maintain all equipment used for microbiology work To propagate, maintain and store all Microbial cultures To prepare documents (Report, SOP, IOP) as and when required Preferably female candidates  Candidates from the enzyme industry are preferred.    Education : B.Sc / M.sc Microbiology   Candidate with the experience in Parenteral ...

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 ...

Overall Administrative &Technical responsibilities of the laboratory  An authorized signatory for biological testing –microbiology for NABL logo.  Preparation and submission of new industrial project proposals.  Method validation and verification for microbiological methods  Organizing multitude of Seminars , Presentations and International Training prog’s on Microbiology.  Participation in Training prog on Quality systems  Microbiological analysis of food, water, ...

Must be able to perform analysis from the following analytical equipment: GC, HPLC, Karl Fischer Titrator, pH Meter etc. Analysis of raw materials, sampling of raw materials maintenance work record, preparation of certificate of analysis, calibration instruments etc. Maintain all analytical equipment according to the schedule and Standard Operating Procedures (SOP’s). Complete all ...