5.0 - 10.0 years

0 Lacs

haryana

On-site

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

Posted 1 month ago

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