Seagen

Regulatory Project Management, Director

Description

Summary:

Reporting to the head of Regulatory Operations, the Director of Regulatory Project Management (RPM) provides strategic and tactical leadership to the RPM group and manages several regulatory teams directly as well. This position serves as an essential partner of and support for the Global Regulatory Leads (GRLs) and Teams (GRTs) and will ensure they receive RPM project planning and team support for the successful execution of their goals and activities. They will manage the RPM group, establish their procedures, be the business owner for regulatory project management systems, and serve as an individual RPM contributor as required. They will also ensure that RPM maintains and manages complaint project plans for each GRT within our corporate systems. They will also, hire, build and develop the group as needed, within the budget, and in collaboration with Regulatory Affairs leadership.

Principal Responsibilities:

• Managing direct reports to ensure the team provides the necessary GRT project management support to successful meet time-sensitive regulatory timelines in a manner compliant with governance and product teams’ goals
• Use strong project and organizational knowledge and facilitation to establish the RPM team's processes and manages their execution of all GRT project plans and deliverables for early-stage clinical and late-stage marketed products to enable effective team meetings and high-performance teams
• Manages team-level and corporate processes effectively, using strong project and process knowledge to drive high-quality integrated project plans and team deliverables, and assures Regulatory Affairs is complaint with the use of the Planisware system and processes for the management and archive of all GRT project information and plans
• Facilitates the development of integrated cross-functional product regulatory strategies and plans
• Hire, coach, mentor, develop and manage performance of team members to maximize their contributions and personal growth
• Directly manages several GRT by managing and coordinating their meetings, sites and preparing project plans / program timelines, dashboards, agendas, recording meeting minutes and tracking action items
• Collaborate with Regulatory Science and other functional areas (Clinical, Drug Safety, Medical Writing, CMC Technical Writing, Nonclinical, Pharmacology, Biometrics, Data Management, Marketing, Program Management, etc.) to develop and maintain regulatory plans and ensures deliverables are meet in a timely manner
• Becomes a liaison between GRT team members and senior management identifying and escalating critical path issues, risks, resource needs and alternative scenarios to achieve objectives.
• Assess program critical path issues, alternative plan scenarios, areas of risk, mitigation plans and resource needs, and communicates and presents program status and opportunities to stakeholders including product teams, management and governance to assist in decision making
• Contributes to the functional excellence of Regulatory project management by participation in the development and continuous improvement of processes, procedures, and tools related to program and portfolio management practices

Qualifications:

• At least 15 years of experience in the biotechnology or pharmaceutical industry, including at least 10 years in drug development and/or regulatory project management functions

Education

• Bachelor’s degree preferably in a scientific discipline or business-related field
• PM certification preferred.

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. 

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/29/2021