JOB DESCRIPTION
:Job Responsibilities
Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. Manage execution of CMC documentation including PIND/IND/CTA , original NDA/MAA , agency background packages and responses to health authority questions per established business processes and systems.



Support new technology development within our Company. Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Branded products worldwide. Conduct all activities with an unwavering focus on compliance. May need to manage or mentor junior team members. Technical Skills:
Hands of expertise of preparation & review of dossiers , response to queries, communication with agencies for developed markets like US/EU Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Robust listening skills. Demonstrated sound understanding of re

📌 Senior Manager, Regulatory Affairs (Gurugram)
🏢 SUN PHARMA
📍 Gurugram