Regulatory Oncology Program Manager

Duration: 6-9 months, potential extension

The Regulatory Program Manager (RPM) will be an asset-level operational leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of cross-functional team efforts. The RPM will serve as the primary project management point of contact to ensure Regulatory functional plans are aligned with compound/program objectives and commitments. RPMs will work closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs as well as Project Management, Medical Writing, Clinical and other key functions to ensure confidence, quality, and speed in the delivery of the Oncology portfolio.

Key Responsibilities:

• Empower teams to deliver the highest possible impact for our programs, business, and patients around the world.
• Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. (e.g., MSP project plan, risk and opportunity playbooks, scenario evaluation and business case development).
• Lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of worldwide submissions, driving processes to optimize global filing and launch strategy, pre- and post-submission activities, preparation for health authority meetings and additional major regulatory milestones.
• Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making, challenging status quo, and fostering impactful innovation.
• Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required.
• Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team including co-development partners and/or other external partners, as required. Liaise with Compound Development Team (CDT) and Senior Leadership Team (SLT) partners to prepare discussions and drive meeting outcomes.
• Lead the operational execution of select marketing applications including, clinical variations and Pediatric submissions, partnering to ensure alignment of Regulatory and compound submission strategies, developing clear and detailed plans, ensuring team roles, responsibilities and accountabilities, and positioning teams to proactively mitigate risks and enhance opportunities.
• Drive process improvements and embed best practices from across programs, TA’s and functions into supported teams.
• Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery.
• Build RPM value proposition through continuous refinement of delivery, prioritizing and focusing on areas of highest impact and opportunity, and actively leading efforts to enable enhanced capabilities and impacts.
• Serve as a mentor and coach to other RPMs and team members.
• As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.
• Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required.

Education:

• A minimum of a Bachelor’s degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs, or a related discipline. Advanced degree preferred.

Required:

• Proficient knowledge of MS Project (MSP)
• A minimum of 5 years of industry/business experience is required.
• A minimum of 3 years of experience in a Pharmaceutical, Med Tech or comparable R&D area is required.
• Experience in strategic planning and development of global regulatory strategy, and cross functional management of global regulatory…