Senior Analyst, Regulatory Program Manager

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

Job Function:

Project/Program Management Group

Job Sub Function:

R&D Project Management

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

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

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-025745

• Netherlands. Belgium - Requisition Number: R-026426

• United Kingdom - Requisition Number: R-026427

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Analyst, Regulatory Program Manager - Oncology.  This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; Horsham, PA; or Spring House, PA.

The Senior Analyst, Regulatory Program Manager (RPM) is an asset-level operational leader, driving programs and projects forward through the translation and distillation of overall global regulatory strategy to executable plans and ensuring successful coordination of cross-functional team efforts.  This individual will serve as the primary project management point of contact to ensure Regulatory functional plans are aligned with compound/program objectives and commitments working closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs, 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.  Support regulatory and compound project teams directly as well as work internally within the RPM department to enhance and ensure robustness in critical business processes.  The Senior Analyst, RPM is guided in all matters by the Johnson & Johnson Credo and held to Johnson & Johnson Leadership Performance Standards.

Principal Responsibilities:

• Function as a change management and implementation leader for new process and system rollout across the RPM team.

• Lead operations with Global Regulatory Team (GRT), including activities such as ensuring visibility to and/or management of health authority meeting planning, worldwide submissions, driving processes to optimize global filing and launch strategy, and key deliverable in early and late development stages including consolidation of regulatory strategy, pre- and post-submission activities and preparation for health authority meetings.

• 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).

• 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-perfo