Global Regulatory Lead

2 weeks ago

Gurgaon, Haryana, India Sun Pharmaceutical Industries Full time

The Associate Director Director Global Regulatory Leader Global Regulatory Affairs GRA Specialty Business Brands and Innovative Medicines partners with leaders across the organization to be the face of the asset from a regulatory perspective The role will be responsible for formulating developing and executing a comprehensive regulatory strategy integrating US and ex-US regulatory requirements and health authority engagements to drive product development global registration and ultimately desired labeling for one or more assets within or across therapeutic areas The position would also act as a US agent Responsibilities Provide strategic tactical and operational direction and guidance to product teams for assigned inline and or pipeline assets in one or more therapeutic areas Develop socialize execute and maintain the regulatory commitments and requirements for assigned assets Retain contemporary knowledge of regulations directives guidelines and policies that may have an impact on product development to assess approval pathways and associated risks Identify and communicate issues to management related to product development that could impact effective regulatory execution Set and monitor submission timelines along with other key stakeholders In association with other regulatory leaders facilitate and lead communications with health and or competent authorities where applicable Ensure is in accordance with established procedure within the department Must be involved in writing or to facilitate the authoring of certain sections of product submissions dossiers Develops and manages relationships with external regulatory agencies industry groups and business partners As applicable shall review the audit reports Regulatory Agency inspection reports and responses to the inspection observations if any when received Compiles prepares and reviews regulatory submissions to regulatory agencies as applicable may be the US agent for selected assets Conduct department level training as necessary to educate regulatory strategists and other roles in the department on regulatory requirements policies and procedures Participate in authoring and or reviewing of the departmental procedure as applicable Qualifications Advanced degree preferred PhD MD PharmD MBA JD Minimum of 10 years of experience within global regulatory affairs in the pharmaceutical ideally or biotech industries A thorough understanding of drug development process and regulatory requirements for product development across modalities and disease areas Direct experience authoring and filing clinical trial or marketing applications across major regulated markets and a knowledge of the developing biologics regulations

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