Regulatory Oncology Program Manager

Medasource; New Jersey; On-site; USD 100,000 - 130,000; Full time

Job summary

A leading healthcare consulting firm is seeking a Regulatory Program Manager in New Jersey. This role involves driving global regulatory strategy into executable plans and coordinating cross-functional teams. The ideal candidate will have significant operational leadership experience, familiarity with regulatory submissions, and a strong background in project management. Required qualifications include a Bachelor's degree and proficiency in MS Project, with at least 5 years in relevant industry experience., Providing strategic oversight to ensure the success of the Oncology portfolio is essential.

Qualifications

• Minimum of 5 years of industry/business experience required.
• Minimum of 3 years in Pharmaceutical, MedTech or comparable R&D area required.
• Experience in strategic planning and development of global regulatory strategy required.

Responsibilities

• Drive projects through translation of global regulatory strategy.
• Empower teams to deliver impact for programs and patients.
• Ensure alignment of functional plans with compound objectives.

Skills

Project management

Strategic planning

Regulatory knowledge

Communication

Innovative thinking

Education

Bachelor’s degree in Life Sciences or related field

Tools

MS Project

Job description

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, MedTech or comparable R&D area is required.
• Experience in strategic planning and development of global regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g., NDA, MAA, and lifecycle documents) is required.
• Demonstrated understanding of Global Regulatory Affairs processes 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 is required.
• Knowledge of global regulations, guidelines and regulatory requirements is required.
• Proficiency and demonstrated application of project management standards, planning and visualization tools is required.
• Regulatory certification (RAC) preferred.
• High proficiency in reporting tools and experience in report development is highly preferred.
• High proficiency with Microsoft Project in server and/or online environment 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.