Sr. Manager,Regulatory Program Management - Immunology

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

About Immunology

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 Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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.

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.
• 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.
• 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.
• 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.
• Drive process improvements and embed best practices from across programs, TAs, and functions into supported teams.
• Act as operational owner of the Global Filing and Launch Strategy.
• 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.
• Serve as a mentor and coach to other RPMs and team members.

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’ experience of industry/business 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 is required.
• Project management experience leading global regulatory teams in a matrix setting is required.
• Demonstrated 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.
• Proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required.
• Must have excellent verbal and written communication skills.
• The ability to resolve controversy and influence teams without formal authority is required.
• This position will require up to 10% domestic and international travel.