22 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 ...

Position:         Executive - QA/RA Location:        Daman Experience:     5 - 8 Year Industries:      Pharma  Responsibilities: Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities Coordinate with various departments to collect the complete set of documents. Review of the quality and analytical data as ...

WE ARE HIRING!!!JOB LOCATION: Bangalore,IndiaDEPARTMENT: Verification and ValidationREQUIRED EDUCATION: Bachelor’s degree in EC/Biomedical engineeringKEY RESPONSIBILITIES: • Review product, user and technical system requirements forcompleteness, feasibility, and testability of the product and/orsystem• Define and implement system integration and test protocols(including embedded, mobile and web services software, as wellas electrical and mechanical ...

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 ...

KEY RESPONSIBILITES: • Team Handling.• Assist/guide team member to enable them for below: Ensure timely compilation & submission with best quality of Dossiers, (Asia, Africa, CIS and LATAM) and maintain proper records of the same.• Handling queries for Asia, Africa, CIS and LATAM.• Query tracker updates on weekly basis.• Timely response ...

The job description is as below: Candidate having experience of Dossier Compilation, Liasioning with Regulatory consultant. Collect and compiled documents from each and every department and submit to client. Regulatory assistance to client. Preferable experience in ROW, Middle East and Latin America Market. Office time: 9:00 AM to 5:30 PM Job location -Mehsana for further details call ...

Role: • Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols. • Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports. • Drafting and revising pre-clinical summaries. • ...

Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline. Technical documents like Raw Material and finished products specification, manufacturing process, Product development report, stability reports, process validations preparation & review. Analytical method validation review as per the ICH guideline. Drug Master File review Technical query response to the ...

Quality Assurance Specialist Responsibilities: Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). Conduct internal quality audits and participate in management review meetings. Handle investigations of complaints and implement corrective and preventive actions. Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in ...

The job description is as below: Keep in touch with international legislation, guidelines and customer practices  Keep up to the date with a company’s product range Ensure that a company’s products comply with the current regulations. Coordinate, prepare and review all appropriate documents, for example, dossier and submit them to regulatory authorities within a ...