Endo International plc Hiring for Regulatory Affairs Associate (Mumbai) at Ghatshila, Jharkhand, India

Associate position will be responsible for the labeling US Market.

Job Description

• 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.

Qualification & Experience:

B.Pharm/ M. Pharm/M.sc with minimum one year relevant experience.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.