**Job Title:** Group Leader US & OAM **Job Grade:** G8 **Department:** Regulatory & Business Continuity **Business Unit/ Division** R&D Baroda **Managers Job Title:** Group Leader Regulatory & Business continuity for US/OAM **Span of control** **Direct:** **Total:** 6 **Reporting structure** Direct to Head **Job Description** **Version and date** 1.0 / 10-Oct-24 **Area Of Responsibility** 1. Actively involved in development, filing related activities for products assigned to team members. 2. Pre-filing activities: Guidance/review of various correspondences with the agency like controlled correspondences, Pre ANDA, NDA meetings, HF, FOI requests, etc. 3. Pre PIF-evaluation for US products. 4. Regulatory operations: Shared goals, R&D Metrics, Approval calendar, QRM, Budget, Approval benchmarking, Portfolio management 5. Cross functional team support to Baroda/Gurgaon/Princeton - Technical/guidance/providing information 6. Work planning for Baroda team 7. Ensuring team productivity and optimal utilization of resource 8. Allocation of RA scientist to all DF products 9. Recruitment, retention and development of talent 10. Ensure timely and quality filing to ensure timely approval 11. Managing changing requirements/expectations from the Agencies 12. New process establishment for smooth functioning of department 13. Creation and maintenance of various data base for ease of referencing, trend data analysis for management review 14. Technical communication for dossier filing 15. Resolution/trouble shooting/de bottlenecking wherever required during Pre-filing, filing and post filing. Geographic Scope/ Market US, EU, Japan, Australia, Canada Work Conditions: Full time Physical Requirements: Presence at work Travel Estimate Infrequent **Education and Job Qualification** + M. Pharm + Having knowledge and good understanding of the filing requirements for ANDA/NDA/INDs, Query responses, Pre-filing development related activities, Pre PIF-evaluation for US. + In-depth knowledge of filing requirements for ANDA/NDA/INDs, Pre-filing development related activities good understanding and interpretation of USFDA guidances which helps to define correct strategy. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.