Senior Executive / Assistant Manager - Regulatory Affairs - API

As the Manager of India OSD Pre-approval ANDA portfolio, Injectable Drug Substance pre-approval portfolio, and Global DMF Review portfolio, your primary responsibilities involve providing Drug substance/nitrosamine review support to complex projects, including 505(b)(2), Europe & Canada projects. You will also participate in cross-functional meetings to address regulatory/technical issues and facilitate decision-making processes. Additionally, it is essential to engage with API vendors to gather relevant information and prevent any deficiencies in Drug Substance. Your role also encompasses bridging DMF/API related regulatory decisions between Raks & Amneal Teams, conducting training sessions on regulatory topics, and ensuring the quality and compliance of critical documents/submissions related to DMFs, ANDAs/S, and Amendments. Furthermore, you will be responsible for formulating RA Strategy of ANDA/DMF/DS for ongoing projects, ensuring timely submissions to regulatory authorities, leading the Global DMF Team/Process, and coordinating global regulatory efforts for DMF/API between Raks, Amneal India & Amneal USA teams. Innovation and continuous improvement are key aspects of your responsibilities, as you will be developing RA tools, coordinating with SSSM team/vendors for document requirements, resolving DMF critical issues, and supporting audits with necessary regulatory information. Your role will also involve evaluating critical change notifications, supporting launch activities, handling team management and development, project distribution, resource planning, and candidate selection processes. Additionally, you will conduct yearly performance appraisals, approve team attendance, and ensure compliance with regulatory submissions. The ideal candidate for this role should have an M. Pharm / M. Sc. qualification and possess strong leadership skills, regulatory knowledge, and the ability to drive regulatory compliance across various projects and teams effectively.,