You will be the Global Regulatory Lead for assigned commercial products for an innovative big pharma based in Massachusetts.
This group is responsible 30% of the company’s revenue offering enhanced visibly to upper management.
You will be working for one of the top employees in Massachusetts across a variety of therapeutic areas.
• Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing the field as applicable.
• The Associate Director will be responsible for increasingly complex or multiple projects.
Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs.
• Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed.
• 8+ years of pharmaceutical industry experience.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.