Job Description Summary
Assistant Manager Regulatory Affairs Labeling will be responsible for Labeling activity/ Submissions for US market.
Job Description
- Job Descriotion:
- Preparation, review, and compilation of Module - I (Administrative / Labeling Section) as per e-CTD formats and complying the labeling requirements.
- Prepare, assemble, review, and/or evaluate eCTD formal FDA submissions for ANDAs, as well as its amendments (Complete Response, Information Request and ECD), supplements (CBE, CBE - 30 and PAS) and annual reports.
- Active participation in regulatory activities for allotted projects, query responses, post-approval changes and coordinate filing requirements of submissions within a time to ensure the compilation of quality regulatory submissions.
- Ensure the electronic submission is accurate and complies as per the RTR, content & format of submission with current Agency's requirements.
- 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.
- Monitoring the Orange book cumulative monthly update for Patent and Exclusivities and ensure the Labeling, Patent & exclusivities for product accordingly by communicating the same to Legal group.
- 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.
- Ensure the submission have all the necessary documents and communicate the same.
- Closely observe the REMS documents to align as per the Approved Labeling.
- Monitoring the REMS@FDA to have proper labeling directions for patient guidance.
- Also, ensure the post-approval submissions as per the committed timeline to ensure compliance.
Education And Experience
M. Pharm/ M. Sc with 6-8 years 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.
