1.Preparation and submission of registration dossier in CTD/ACTD /country specific format .
2.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.
3.Ensuring that quality standards are met and submissions meet within stipulated timelines.
4.Responsible for Compilation & Review of Quality documents like RM/FP , STP, Stability Protocols & Report, Process Validation protocols & reports, Analytical method validations.
5.Liaise with marketing for the finalizing the product pipelines and providing required dossiers for submissions
6. Prepare accurate and timely responses to queries received from regulatory agencies.
7. Checking & approval of artworks as per countries requirement.
8. Arranging samples, working standard, artwork as per country requirement and submit them to
Regulatory authority within specified time frame.
9. Communicate and follow up with agent for progress of registration submission.
10. Maintain record for the Dossier and sample submission.
11. Maintaining & updating country wise registration status and arranging for renewal.
12. Filling Tender with samples and technical documents within specified time frame.
Desired Candidate Profile
- 1-6 years of experience in Regulatory Affairs only, preferably in the pharmaceutical industry.
- Bachelor's degree in Pharmacy (B.Pharma) or Master's degree (M.Pharma).
- Solid knowledge of CTD, ECTD, Dossier Preparation, Regulatory Submissions.