Opening for Executive / Sr. Executive - Regulatory Affairs (API)
Education: M.Sc. (Organic Chemistry)
Experience: 3 - 6 yrs
Review all data and documents related to product registrations for various health authorities
Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/OpenParts for In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation.
Prepare responses to deficiency letters received from various agencies for expeditious approval.
Preparation of Regulatory Amendments / Variations for smooth API supplies.
Provide regulatory support to cross functional departments.
Re-position of regulatory database and compliance to procedures.
Salary: Not Disclosed by Recruiter
Role Category:Drug Regulatory Affairs/Documentation
Role:Regulatory Affairs Manager
Employment Type:Full Time, Permanent
Desired Candidate Profile
UG:B.Sc - Any Specialization
PG:MS/M.Sc(Science) - Chemistry, Any Specialization
Doctorate:Doctorate Not Required
Sun Pharmaceutical Industries Ltd
Recruiter Name:HR Department
Contact Company:Sun Pharmaceutical Industries Ltd