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Associate Director, Regulatory Project Management

Cambridge, MA

Posted: 02/14/2019 Job Category: Clinical: Regulatory Job Number: 2269

The Associate Director, Regulatory Project Management is responsible for leading strategic planning and execution of the Regulatory and cross-functional teams to ensure regulatory deliverables (regulatory plans, health authority meeting execution, regulatory assessments) are achieved.

Job Responsibilities:
  • Co-lead with regulatory lead and facilitate 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.
  • Expected to develop and manage timelines supporting regulatory submissions, identify risks and develop 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 the components of the regulatory submission and be responsible for driving the cross functional project teams and achieve timely regulatory submissions.
  • Plans and maps out upcoming regulatory activities, development of master timeline for critical submission (e.g., NDA/BLA), coordinate within and outside the department necessary activities supporting submissions.
  • Orchestrates and maintains regulatory project management information needed for project teams; manages project status reporting to Senior Management, project teams, and, ad-hoc updates.
  • Ability to prioritize projects and activities in a fast-paced environment is required. 
  • Develop SOPs supporting the department.
  • Identifies and leads innovative process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include process and system improvements. Mentor and train junior staff.

Requirements / Qualifications:
  • Bachelor’ s Degree in a science discipline. Advanced degree is preferred.
  • 8-10 years of regulatory experience with increasing responsibilities in Regulatory Project Management.
  • Demonstrated experience in leading decision-making within 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 is required.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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