Title:  Global Regulatory Lead

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