Manager, Regulatory Program Manager Immunology

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 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.

Learn more at 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-036921

Belgium - Requisition Number: R-037688

United Kingdom - Requisition Number: R-037690

Switzerland - Requisition Number: R-037703

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

We are searching for the best talent for Manager Regulatory Program Manager Immunology to be located in High Wycombe United Kingdom. This is a hybrid position and requires you to be onsite 3 days a week.

Purpose:

The Manager 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. 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. 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 Manager 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 TAs 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:

• A minimum of a Bachelors degree is required preferably in Life Sciences Business Management Regulatory Affairs or a related discipline. Advanced degree preferred.
• A minimum of 5 years of industry/business experience.
• A minimum of 3 years of experience in a Pharmaceutical MedTech or comparable R&D area.
• 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.
• Demonstrated understanding of Global Regulatory Affairs processes.
• Project management experience leading global regulatory teams in a matrix setting.
• Experience conducting business processes 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.
• Experience driving and expediting team decision-making and translate strategy to clear executable action plans.
• Experience resolving controversy and influencing teams without formal authority.
• Experience influencing decision-making at all levels and representing project teams with senior leadership and governance bodies.
• This position will require up to 10% of domestic and international travel.

Preferred:

• Experience leading submission teams and working with external partners.
• Project management certification.
• Regulatory certification (RAC).
• Proficiency with Microsoft Project.

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