Are You Passionate About Ensuring Pharmaceutical Products Meet Regulatory Standards To Improve Patient Safety And Quality Of Life? Join Endo India Par Formulations As A Regulatory Affairs Associate In Mumbai! At Endo, We're Dedicated To Developing, Manufacturing, And Marketing Safe, Innovative, And Cost-Effective Pharmaceuticals. Our Commitment To Ethical Standards, Investment In State-Of-The-Art Equipment And Facilities, And Expanding Product Portfolio Make Us A Company Where You Can Build A Fulfilling Career With Long-Term Potential.
- Position: Regulatory Affairs Associate
- Department: Regulatory Affairs
- Education: B.Pharm / M.Pharm / MSc
- Job Location: Digha
Job Description
- Monitor The Drugs@FDA Site Daily For RLD Labeling Revisions And Ensure Labeling Compliance For All Under Review And Approved Products.
- Oversee the NDC Database, Medication Guide/PIS Distribution, And Daily Med Updates To Identify Revisions For Annual Reportable Changes.
- Coordinate With Cross-Functional Teams And Vendors For Artwork And Print Proof Approval.
- Ensure Commercial Labeling Is Free From Medication Errors.
- Stay Updated On the Agency’s New Guidance That May Affect Current And Future ANDAs.
- Review And Enhance Knowledge From SBIA Webinars And REdI Guidances.
- Prepare, Review, And Update Departmental Standard Operating Procedures.
- Maintain Radius Submissions, ANDA & API Track Sheets Using Excel.
- Review And Prepare New And Commercial ANDA Labeling Components In Compliance With FDA Guidance.
- Prepare Documents Related To Artwork Review And Approval And Share With Other Departments.
Candidate Profile:
- Education: B.Pharm / M.Pharm / MSc
- Experience: Minimum One Year Of Relevant Experience In Regulatory Affairs.
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
Join Us In Our Mission To Make A Difference In Patients’ Lives Through Regulatory Excellence. Apply Now And Be Part Of A Dynamic Team Driving Innovation And Compliance In The Pharmaceutical Industry!
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