AD, DQA, F&D, Regulatory Affairs Jobs at Ciron Drugs & Pharmaceuticals

Ciron has carved a niche for itself in the sphere of operations of manufacturing Ampoules, Vials, Eye / Ear / Nasal drops, Lyophilized products and Lyophilized bulk. Manufactured in India, these niche products help make CIRON market-friendly in India and abroad. Along with training of technical personnel, CIRON invests almost 40% of its Annual Profits in acquiring the latest machinery for its plant; ensuring a constant upgrade in the quality of its products, keeping them in line with the finest in technology.

Post: ADL/ DQA/ F&D (OSD & Injectables)- Officer to Team Leader; Regulatory Affairs - Officer & Executive

ADL/DQA/ F&D (OSD & Injectables)- Officer to Team Leader
Qualification : B.Pharm & M.Pharm
Experience : 2 yrs to 10 yrs
Location : Navi Mumbai

Regulatory Affairs - Officer & Executive
Qualification : B.Pharm & M.Pharm
Experience : 3 yrs to 7 yrs
Job Description
1.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.
2.Coordinate with other 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

Location : Goregaon