Manager - Branded Regulatory

As a Manager/Senior Manager in the Global Regulatory Affairs department based in Gurgaon, you will play a crucial role in providing Regulatory CMC Product Leadership for branded products being developed for advanced markets such as the US, EU, and Canada. Your responsibilities will include ensuring timely submission of annual reports and supplements for product continuity, assessing regulatory milestones, and developing CMC Regulatory Strategy Documents for projects of increasing complexity. You will lead regulatory activities in product in-license/due diligence review, product divestment, and product withdrawal. Your role will involve managing the execution of CMC documentation, supporting new technology development, and demonstrating unwavering focus on compliance in all activities. Additionally, you may be required to manage or mentor junior team members. Your technical skills will be crucial in handling preparation and review of dossiers, responding to queries, and communicating with agencies for markets like US and EU. Your experience in critically reviewing scientific information, effective communication in multicultural settings, and ability to generate innovative solutions to complex regulatory problems will be essential. The ideal candidate for this role should hold an M.Pharm in pharmaceutical sciences with 10-15 years of hands-on experience in regulatory affairs. Proficiency in English is a must, and additional language skills are a plus. Strong leadership, communication, interpersonal, and negotiating skills are required for effectively working with key stakeholders and leading a team of professionals in a dynamic regulatory environment.,