Regulatory Affairs Associate Mumbai – Join Endo India Par Formulations

Regulatory Affairs Associate Mumbai – Join Endo India Par Formulations

Regulatory Affairs Associate Mumbai at Endo India Par Formulations

Location: Mumbai, India – Digha

Time Type: Full-time

Job Requisition ID: R001268

Job Description Summary: The Regulatory Affairs Associate position at Endo India Par Formulations in Mumbai is responsible for labeling activities for the US market.

Job Description:

• Monitor the Drugs@fda Site daily for RLD Labeling revisions and ensure up-to-date labeling for all products under review and approved, implementing changes commercially as needed.
• Maintain the NDC# database, distribute Medication Guides / PIS’s, update Daily Med, and identify revisions for the Annual Reportable Changes.
• Coordinate with cross-functional teams and vendors for Artwork and Print proof approval, ensuring compliance with dimensions.
• Ensure the Commercial Labeling is free from medication errors.
• Stay updated on Agency’s new guidance that may impact current and future ANDAs.
• Review and enhance knowledge from SBIA Webinars and REdI Guidance’s.
• 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 line with current FDA Guidance.
• Prepare and review documents related to Artwork review and approval, collaborating with other departments.

Qualification & Experience:

• Bachelor of Pharmacy (B Pharmacy) / Master of Pharmacy (M Pharmacy) / MSc with a minimum of one year of relevant experience.

Apply online

Commitment to Diversity, Equity, and Inclusion: Endo is committed to diversity, equity, and inclusion, fostering a culture that values each person’s unique perspective. We promote inclusivity across race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all other characteristics, qualifications, skills, achievements, and contributions that make us a diverse and empowered team.