Associate Director, Regulatory Program Manager (1 of 7) - 2306158971W

　　Description

　　Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regulatory Program Manager. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Beerse, Belgium or Leiden, Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the company.

　　At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

　　Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

　　The Associate Director, 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.

　　The RPM role is a Delivery Unit focused either in Immunology, Oncology, Neuroscience, Pulmonary Hypertension, Infectious Disease or Cardiovascular and Metabolism, and aligned with JJIM’s organizational and portfolio support structure.

　　The Associate Director, RPM will be deployed in support of JJIM’s most complex programs, called on to lead critical department initiatives and may represent the function with organizational leadership and in larger capability enhancement efforts at cross-functional and organizational levels. This individual will be expected to provide coaching, education and mentoring to more junior staff and select team efforts, while driving continuous enhancement of RPM impact for the organization.

　　Principal 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 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

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

　　A minimum of 7 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) 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.

　　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.

　　Experience driving and expediting team decision-making and translating strategy to clear, executable action plans is required.

　　Experience resolving controversy and influencing teams without formal authority is required.

　　Experience influencing decision-making at all levels and representing 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 in the San Francisco Bay Area, CA is $166,000 to $267,145.

　　The anticipated base pay range for this position in all other U.S. locations is $135,000 to $232,300.

　　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 year

　　For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

　　The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

　　Primary Location NA-US-Pennsylvania-Spring House

　　Other Locations NA-United States, NA-US-Pennsylvania-Horsham, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-US-New Jersey-Raritan, NA-US-New Jersey-Titusville

　　Organization Janssen Research & Development, LLC (6084)

　　Relocation Eligible: Yes - Within Country

　　Job Function Regulatory Product Submissions and Registration

　　Req ID: 2306158971W