Experience:4 to 8 years
- Preparation of Drug Master Files (DMF) in CTD / eCTD / Nees format for US, European Countries, Canada, Australia, Japan, GCC, Turkey and Korea as per customer/ business requirement.
- Preparation of amendments/ Annual Reports to USDMFs, CEP variations, EDMF Updates, Biannual updates to Canada DMFs and Annual updates to Korea DMFs, Japan DMFs.
- Review and approval of change controls.
- Submission of notifications to the customers pertaining to regulatory submissions as per the applicability.
- Responding to deficiency letters received from various regulatory agencies like USFDA, EU Agencies, TGA, Health Canada etc.
- Hands-on experience in Electronic submissions-Lorenz.
- Maintaining query database and response timelines.
- Tracking of variation submission timelines (Amendments, Annual Reports) to various Health Authorities
- Responsible for organizing meetings to address queries and variation submissions.
- Rendering customer support by preparing technical packages, Applicant" s Part Drug Master Files and responding to the technical queries received from customers.
- Analytical interpretation, trouble shooting & Plant performances.
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Role:Regulatory Affairs Manager
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Role Category:Drug Regulatory Affairs/Documentation
Employment Type:Full Time, Permanent
PG:M.Pharma in Any Specialization,MS/M.Sc(Science) in Any Specialization
Hetero Drugs Limited
Contact Company:Hetero Drugs Limited
Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India