Company Description AMN Life is a leading manufacturer and exporter of a wide range of pharmaceutical formulations, offering therapeutic segments such as antibiotics, gastro, anti-inflammatories, cardiology, diabetic, nephrology, CNS, and oncology. Headquartered in Bandra Kurla Complex, Mumbai, with offices in Singapore, the UK, Australia, and the Philippines, AMN Life has a global presence. With over 20 years of experience and more than 500 product registrations worldwide, we are committed to providing quality medicines at affordable prices. Our EU, Health Canada, Brazil Anvisa, and Philippines-approved facilities are equipped for large-scale manufacturing and successful tech transfer projects. We are dedicated to innovative R&D and maintaining the highest quality standards. JOB DESCRIPTION: 1. Dossier preparation, review submission in ACTD/ CTD/ Country Specific format for Product registration for local and export to ensure error free timely submissions as per marketing Dept. timeline. 2. To evaluate respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query. Ensure accurate and timely responses to queries. 3. Review technical documents like process validation, AMV, Stability and composition etc, labeling, batch records, specification sheets or test methods for compliance with applicable regulations and policies. 4. To Co-ordinate / to visit with respective dept. in HO / Plant / ADL / R D for documents samples required for dossier / registration purpose. Co-ordination with API / PM vendors to resolve technical quires w.r.t. regulatory requirements. 5. Artwork Checking development for registration and commercial purpose as per regulatory requirement Ensure that all product artwork is updated when necessary and submitted in correct format and subsequent approved artwork is accurately recorded and communicated. Handling local FDA, DCGI and regulatory related activities. 6. Ensuring accurate recording and communication of regulatory submissions, correspondence with authorities and final approval to facilitate compliance. Job Type: Full-time Schedule: Day shift Supplemental pay type: Yearly bonus Experience: 3 to 8 years Work Remotely: No Job Type: Full-time Benefits: Health insurance Provident Fund Work Location: Workafella, 1st Floor, Western Pearl Building, Hitech City Road , Opp HDFC Bank, Kondapur, Hyderabad , Telangana 500084 Total work Experience Required : 2-4 years (Preferred) Salary Range- 3-4 LPA Please feel free to connect @8976869261 and share your CV at /
Job Title
Senior Officer RA