Experience: 5 - 10 Years
Desired Candidate Profile
• M.Sc organic or analytical chemistry with 5-10 year experience of compilation of DMFs in API regulatory department.
•Knowledge of regulatory requirements for APIs and Formulations in major regulated market
•Knowledge & experience of filling variations, changes.
•Knowledge cGMP/QA systems
•Should have good knowledge on ICH guidelines, process validations, cleaning validations, stability studies guidelines, impurity profiling, annual product reviews, change controls, deviation controls etc
•Good knowledge of development and commercialisation process
Job Description
•Preparation of DMFs for registration in regulated market Europe, USA, Japan, Australia, Canada etc
•Keeping existing DMFs in current status
•Filing of Annual reports, DMF amendments
•To prepare answers to deficiency letters and statements, communications required for registration activities
•Checking the documents received for DMF filing as per current regulatory requirement
•Timely regulatory support/advice to all API sites /FDF sites.
•To train API sites for Drug Master file documentation.
•Maintenance of various lists/document submission records, communications, DMF submission records
•Co-ordination with Formulation regulatory department
•Co-ordination with QA/Production/Development for documents required for DMF filing.
Company Profile
For a reputed client of Digvijaya - Exclusive consultants for Pharma/Biotech/CROs.
Contact Details
DIGVIJAYA MANAGEMENT CONSULTANTS PVT.LTD.,
http://www.digvijaya.com
4D, 4th Floor, Nandanavanam, SR Nagar 'X' Roads,
HYDERABAD,Andhra Pradesh,India 500038
dmcl@digvijaya.com
91-40-23817576
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