Regulatory Affairs - Officer
Expected Experience : 1 to 3 years
No.of Position : 6
Job Location : Goregaon
Job description
Responsibilities:
Preparation and submission of registration dossier in CTD/ACTD /country specific format for countries in CIS, Africa, South east Asia, Latin America and Middle east region.
Coordinate with Plant , R&D & CQA & ADL department for technical documents and to review the documents for accuracy as per ICH or Country specific requirement.
Ensuring that quality standards are met and submissions meet within stipulated timelines.
Responsible for Compilation & Review of Quality documents like RM/FP , STP, Stability Protocols & Report, Process Validation protocols & reports, Analytical method validations.
Liaise with marketing for the finalizing the product pipelines and providing required dossiers for submissions.
Prepare accurate and timely responses to queries received from regulatory agencies.
Checking & approval of artworks as per countries requirement.
Arranging samples, working standard, artwork as per country requirement and submit them to Regulatory authority within specified time frame.
Communicate and follow up with agent for progress of registration submission.
