Senior Manager, Regulatory Program Management – Immunology

Role Overview

• 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.
• 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 sequencing, 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 submission 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, TAs, and functions into supported teams.
• Act as operational owner of the Global Filing and Launch Strategy.
• 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.

Requirements

• A minimum of 7 years’ experience of industry/business is required.
• A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area is required.
• Experience in strategic planning and development of regulatory strategy, and cross-functional management of global regulatory submissions and processes (e.g., NDA, MAA, and lifecycle documents) across various phases of the drug development cycle is required.
• Project management experience leading global regulatory teams in a matrix setting is required.
• Experience leading submission teams and working with external partners is preferred.
• Demonstrated experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines required.
• Knowledge of global regulations, guidelines, and regulatory requirements with in-depth knowledge/focus of FDA/EMA procedures is required.
• Demonstrated understanding of Global Regulatory Affairs processes is required.
• Proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required.
• Project management certification preferred.
• Regulatory certification (RAC) preferred.
• Proficiency with Microsoft Project is highly preferred.
• Must have excellent verbal and written communication skills.
• Must have strong innovative and strategic thinking skills.
• The ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required.
• The ability to resolve controversy and influence teams without formal authority is required.
• The ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year