The cleaned title from the string Manager - Regulatory CMC is Manager - Regulatory CMC . SUN PHARMA

5.0 - 10.0 years

0 Lacs

haryana

On-site

The position of Manager is open in the Global Regulatory Affairs Specialty Pharma department. As a Regulatory CMC Product team member, you will provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded products being developed for the US and other advanced markets like EU & Canada. Your responsibilities will include ensuring lifecycle management by submitting annual reports and supplements in a timely manner to ensure product continuity. You will be accountable for the delivery of all regulatory milestones for higher complexity products, including assessing the probability of regulatory success and implementing risk mitigation measures. In this role, you will lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Additionally, you will provide regulatory leadership in product in-license/due diligence review, product divestment, and product withdrawal. Managing the execution of CMC documentation, supporting new technology development, and ensuring compliance with a focus on regulatory affairs will also be part of your responsibilities. You may also be required to manage or mentor junior team members. As a candidate for this position, you are expected to have hands-on expertise in the preparation & review of dossiers, response to queries, and communication with agencies for developed markets like the US/EU. Your experience in critically reviewing detailed scientific information, demonstrating superior oral and written communication skills, and understanding related fields such as manufacturing, analytical, and quality assurance will be crucial. Your ability to generate innovative solutions to complex regulatory problems, work effectively with key stakeholders, and demonstrate flexibility in responding to changing priorities will be highly valued. To qualify for this role, you should have a minimum of 5-10+ years of experience in regulatory affairs, with proficiency in English and additional language skills considered a plus. Strong inter-personnel skills, the ability to direct multi-departmental functions, and effective leadership, communication, interpersonal, and negotiating skills are essential for this position. A Master's degree in Pharmacy (M. Pharm) in pharmaceutical sciences is required for this role.,

Posted 5 days ago

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