Endo Senior Associate, Regulatory Affairs Job | MPharma Candidates Apply Now
Endo, a global pharmaceutical company committed to advancing patient care, is currently seeking a Senior Associate – Regulatory Affairs (CMC) to join its team in Digha, India. This is an excellent opportunity for experienced professionals with a background in pharmaceutical sciences and regulatory strategy to contribute to the development and timely approval of high-quality generic medicines.
The selected candidate will play a crucial role in compiling and submitting Abbreviated New Drug Applications (ANDAs), managing regulatory amendments, and ensuring compliance with USFDA requirements. If you’re detail-oriented, knowledgeable in regulatory guidelines, and eager to work in a collaborative environment, this role offers a rewarding path in the fast-paced world of pharmaceutical regulatory affairs.
Endo
About the Company: Endo is seeking a Senior Associate in Regulatory Affairs (CMC) to join their team in Digha, India. The company is dedicated to preparing, compiling, evaluating, and submitting ANDAs and amendments to the USFDA, while ensuring timely responses to agency deficiencies.
Job Title: Sr. Associate – Regulatory Affairs (CMC)
Location: India – Digha
Time Type: Full-time
Posted Today
Job Requisition ID: R002510
Job Description Summary
The Regulatory Affairs Senior Associate is responsible for preparing, compiling, evaluating, and submitting
ANDAs and amendments to the USFDA, as well as handling deficiencies by providing timely responses to the agency.Job Description
- Coordinate with cross-functional team/stakeholders (R&D, Quality, manufacturing, SCM, IP, PM) and vendors as required, and evaluation of documents in line with the current regulatory requirements.
- Review of various documents related to product development, specifications, analytical procedures, method validations, stability protocols, and reports
- Preparation, review, and compilation of ANDAs, Amendments, and Supplements in eCTD format
- Monitor the FDA website for any updates.
Education & Experience: Master of Pharmacy in the Department of Pharmaceutics with 3-5 years of experience in Regulatory Affairs
Keywords: Regulatory Affairs, Sr. Associate, CMC, Endo, Job Posting, Digha, India, USFDA, ANDAs, Amendments
