Advertisement
Aizant is seeking a dynamic Regulatory Affairs professional with 3–6 years of experience to manage ANDA dossier preparation, eCTD submissions, and FDA communication for the US market. The role includes end-to-end regulatory lifecycle management and cross-functional coordination.
📝 Key Responsibilities
- Preparation, review, and submission of ANDA dossiers for the US market.
- Compilation and QC of Module 1–5 as per USFDA guidelines.
- Handling eCTD submissions, amendments, labeling supplements, and annual reports.
- Reviewing documents from cross-functional teams to ensure regulatory compliance.
- Responding to FDA queries, deficiency letters, and information requests.
- Monitoring timely submissions, labeling updates, and lifecycle regulatory activities.
- Maintaining complete documentation, regulatory archives, and change controls.
- Coordinating with QA, Formulation, Analytical, and Project Management teams.
🎓 Required Qualifications
- Master’s degree in Pharmacy or a related discipline.
- Mandatory 3–6 years of experience in US Regulatory Affairs.
- Strong knowledge of USFDA regulations, ANDA filing pathways, and eCTD software.
- Excellent documentation, communication, and dossier compilation skills.
- Ability to manage timelines, regulatory queries, and cross-functional coordination.
💼 Why Join Aizant Drug Research Solutions?
- Opportunity to work on high-value USANDA submissions.
- Exposure to advanced eCTD publishing systems.
- Growing organization with strong regulatory and R&D capabilities.
- Collaborative work culture with career-advancement potential.
📍 Job Location
Hyderabad, Telangana
Aizant Drug Research Solutions Pvt. Ltd.
📨 How to Apply
Interested and eligible candidates can send their updated CV to:
👉 sonyjeevitha.degala@aizant.com