Endo India Par Formulations is a pharmaceutical company that develops, manufacturers and markets safe, innovative and cost effective pharmaceuticals that help improve patient quality of life. At Endo our investment in state-of-the-art equipment and facilities, commitment to ethical standards, and growing portfolio of products makes us a company where you can enjoy a productive career with long-term potential.
Post : Regulatory Affairs Associate (Mumbai)
Job Description
• Daily Monitoring the Drugs@fda Site for RLD Labeling revisions, ensure the labeling is up to date for all under review and approved products; also based on changes will ensure in commercial implementation.
• Ensure the NDC; data base, Medication Guide / PIS’s distribution, Daily Med updation; identifying the revisions for the Annual Reportable Changes.
• Communicate the Cross Functional team and vendor for the Artwork and Print proof approval to receive as per dimensions.
• Ensure the Commercial Labeling free from Medication error.
• Follows and monitor Agency’s new guidance’s that may affect current and future ANDAs.
• Review and improve the knowledge from SBIA Webinars and REdl Guidance’s.
• Preparation, review of new and revised departmental Standard Operating Procedures.
• Preparation and maintenance of the Radius submissions, ANDA & API track sheet using Excel.
• Preparation and Review and of new and Commercial ANDA Labeling components in-line with current FDA Guidance for its adequacy and compliance.
• Preparation of Documents related to Artwork review and approval and share it with another departments.
Candidate Profile : B.Pharm / M.Pharm / MSc with minimum one year relevant experience.
Additional Information
Experience : 1 year
Qualification : B.Pharm/ M. Pharm/M.sc
Location : Digha - West Bengal
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th April 2024
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