Ciron Drugs & Pharmaceuticals – Urgent Openings for Regulatory Affairs
Regulatory Affairs Officers/ Executives /Team leader @ Ciron Drugs and Pharmaceuticals Pvt. Ltd
Job location: Jogeshwari
Designation: Officer / Sr. Officer / Executive
Experience: 3years and above
– Compilation, review and timely submission of error free registration dossiers under CTD/ACTD/Country Specific for International market (CIS, LATAM, AFRICA & ASEAN market).
– Co-ordinate with various cross functional team members as well with various functions within F&D, ADL and manufacturing locations for collecting technical data required towards registrations / MOH / customer deficiencies.
– Keeping up to date with changes in regulatory legislations and guidelines.
– Ensuring compliance with regulations set by the regulatory agencies.
– Ensuring that quality standards are met and submissions meet within stipulated timelines.
– Review of Normative Documents (NDs) of products required towards registration in CIS countries.
– Knowledge about CMC section required for dossier compilation.
– Responsible for compilation & review of quality documents like MMF, RM/FP SPCN, 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.
– Liasioning with customers for contract manufacturing/loan licensing towards registrations of the products.
– Responsible for preparation of FDA documents for registration of new product, license for new products (proforma), COPP data compilation & verification.
Interested Candidate can send their resumes at [email protected]