Regulatory Program Manager, Oncology

Company: Disability Solutions
Location: Raritan
Posted on: March 12, 2025

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function: Project/Program Management GroupJob Sub Function: R&D Project ManagementJob Category:ProfessionalAll Job Posting Locations:US026 PA Spring House - 1400 McKean Rd, US054 PA Horsham - 200 Tournament Dr, US063 NJ Raritan - 920 US Hwy 202, US159 NJ Titusville - 1125 Trenton-Harbourton Rd, US337 MA Cambridge - 301 Binney StJob Description:Johnson & Johnson is recruiting for a Regulatory Program Manager, Oncology. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; or Cambridge, MAAbout Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at https://www.jnj.com/innovative-medicineAbout Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at Remote work options may be considered on a case-by-case basis and if approved by the Company.We are searching for the best talent for a Regulatory Program Manager, Oncology. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; or Cambridge, MA.Purpose: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 Johnson & Johnson Innovative Medicine (JJIM) portfolio. The RPM is guided in all matters by the Johnson & Johnson Credo and held to Johnson & Johnson Leadership Performance Standards.You will be responsible for:

• 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 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, 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.Qualifications / Requirements: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.Experience and Skills:
    • 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 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.
    • 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.
    • This position will require up to 10% domestic and international travel.The anticipated base pay range for this position is $115,000 to $197,800.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits:
      • Vacation - up to 120 hours per calendar year
      • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
      • Holiday pay, including Floating Holidays - up to 13 days per calendar year
      • Work, Personal and Family Time - up to 40 hours per calendar yearFor additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThis job posting is anticipated to close on 3/17/2025. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.#Li-HybridAbout Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at https://www.jnj.com/innovative-medicineAbout Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.Learn more at Remote work options may be considered on a case-by-case basis and if approved by the Company.We are searching for the best talent for a Regulatory Program Manager, Oncology. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; or Cambridge, MA.Purpose: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 Johnson & Johnson Innovative Medicine (JJIM) portfolio. The RPM is guided in all matters by the Johnson & Johnson Credo and held to Johnson & Johnson Leadership Performance Standards.You will be responsible for:
        • 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 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, 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.Qualifications / Requirements: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.Experience and Skills:
            • 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 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.
            • 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.
            • This position will require up to 10% domestic and international travel.The anticipated base pay range for this position is $115,000 to $197,800.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits:
              • Vacation - up to 120 hours per calendar year
              • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
              • Holiday pay, including Floating Holidays - up to 13 days per calendar year
              • Work, Personal and Family Time - up to 40 hours per calendar yearFor additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThis job posting is anticipated to close on 3/17/2025. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.#Li-Hybrid

Keywords: Disability Solutions, New Brunswick , Regulatory Program Manager, Oncology, Executive , Raritan, New Jersey