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Director, Regulatory Project Management

Cambridge, MA

Posted: 11/10/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2664

Job Description


Our client is currently expanding its Regulatory team to support the regulatory department and regulatory submissions for programs in development stages and their commercial product. The Director, Regulatory Project Management is responsible for leading strategic planning and execution, ensuring regulatory deliverables are achieved.

Responsibilities:
  • Co-leads and facilitates regulatory team meetings as well as cross-functional submission team meetings to oversee, plan and deliver on regulatory goals.
  • Ensures that the regulatory development strategy is translated into an efficient, executable operational regulatory plan.
  • Leads the project management efforts of the team supporting regulatory submissions for assigned programs including preparation of meeting agendas, drive the submission activities, and document decisions.
  • Actively seeks and involves diverse team perspectives to shape regulatory strategy and drive decision-making.
  • Develops and manages timelines supporting regulatory submissions. Identifies risks and develops adequate risk management solutions in consultation with the cross-functional teams.
  • Works in collaboration with the regulatory lead and the project teams to assemble and coordinate all of the components of regulatory submissions.
  • Plans and maps out upcoming regulatory activities; develops master timeline for critical submissions (e.g., NDA/BLA); coordinates with all stakeholders necessary to support submissions.
  • Manages project status reporting to Senior Management, project teams, and, provides ad-hoc updates.
  • Develops SOPs supporting the department.
  • Identifies and leads innovative process improvements with significant organizational impact and participates in process and system improvements.

 

Requirements / Qualifications:
  • Bachelor’ s Degree
  • 8+ years pharmaceutical industry experience with a minimum of 5 years in Regulatory Project Management.
  • Demonstrated experience in leading a cross-functional, cross-cultural, global team structure in a matrix environment.
  • Experience with project management related software and tools (i.e., MS Project, MS Office, SharePoint etc.).
  • Prior project management experience with NDA/BLA submissions and review

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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