Regulatory Program Manager, Oncology

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.com

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About 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-medicine

We are searching for the best talent for a Regulatory Program Manager, Oncology. This is a remote role available in Vancouver, Canada.

A pre-identified candidate for consideration has been identified. However, all applications will be considered.
 

Remote work options may be considered on a case-by-case basis and if approved by the Company.

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) Oncology 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 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. 
   

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
   

Required:

• A minimum of 6 years of industry/business experience is required
• A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area
• 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)
• Demonstrated understanding of Global Regulatory Affairs processes
• Project management experience leading global regulatory teams in a matrix setting
• Demonstrated experience conducting business process, scenario, and critical path analysis
• Knowledge of global regulations, guidelines and regulatory requirements
• Proficiency and demonstrated application of project management standards, planning and visualization tools
• 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
• The ability to resolve controversy and influence teams without formal authority
• The ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies
• This position will require up to 10% domestic and international travel

Preferred:

• Experience leading submission teams and working with external partners
• Project management certification
• Regulatory certification (RAC)
• High proficiency in reporting tools and experience in report development
• High proficiency with Microsoft Project in server and/or online environment

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.

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