Manager, Regulatory Program Manager - Immunology
Location: High Wycombe, Buckinghamshire, United Kingdom. This is a hybrid position requiring onsite presence 3 days a week.
About Johnson & Johnson Innovative Medicine (JJIM): Our work focuses on innovative medicines and medtech to accelerate breakthroughs that improve health outcomes. Learn more at https://www.jnj.com/innovative-medicine
About Immunology: Our Immunology team develops transformational medicines for immunological disorders and illnesses, restoring health to millions of people living with immune diseases. Learn more at https://www.jnj.com/innovative-medicine
Please note: roles may be posted under different requisition numbers to comply with local requirements. You may apply to one or more postings, but applications are considered a single submission.
Purpose: The Manager, Regulatory Program Manager (RPM) serves as an asset-level operational leader, translating global regulatory strategy into executable plans and coordinating cross-functional team efforts. Acts as the primary PM contact to ensure regulatory plans align with compound/program objectives. Works with the Global Regulatory Leader (GRL) and partners across Global Regulatory Affairs, Project Management, Medical Writing, Clinical, and other functions to ensure confidence, quality, and speed in JJIM portfolio delivery. The RPM is guided by the Johnson & Johnson Credo and Leadership Performance Standards.
You Will Be Responsible For:
* Empower teams to deliver high impact for programs, the business, and patients worldwide.
* Translate regulatory requirements into executable plans, identify and mitigate risks, and create opportunities for acceleration (e.g., MSP project plan, risk/opportunity playbooks, scenario evaluation, business case development).
* Lead operations with Global Regulatory Team (GRT): visibility/management of worldwide submissions, optimization of global filing/launch sequencing, pre- and post-submission activities, health authority meeting preparation, and major regulatory milestones.
* Provide strong operational leadership to Regulatory and program teams, enabling rapid and informed decision making.
* Foster a high-performance GRT culture, facilitating meetings and collaboration as required.
* Coordinate critical regulatory information and communications to ensure timely dissemination of GRT strategy and status, including with co-development partners or external partners.
* Lead operational execution of select marketing applications, ensuring alignment of regulatory and submission strategies, and development of detailed submission plans and roles/responsibilities.
* Drive process improvements and embed best practices across programs and functions.
* Collaborate across functions to establish processes and innovative methods that improve delivery.
* Refine the RPM value proposition, prioritize high-impact areas, and enable enhanced capabilities.
* Mentor and coach RPMs and team members.
* Support budgeting/forecasting and Planisware for regulatory components and project plans.
* Assist activity, resource, and cost planning across the R&D portfolio.
Qualifications / Requirements:
* Bachelor’s degree required (Life Sciences, Business Management, Regulatory Affairs or related); advanced degree preferred.
* Minimum 5 years of industry/business experience.
* Minimum 3 years in Pharmaceutical, MedTech, or related R&D.
* Experience in strategic planning and development of regulatory strategy and global submissions across phases (e.g., NDA, MAA, lifecycle documents).
* Understanding of Global Regulatory Affairs processes.
* Project management experience leading global regulatory teams in a matrix setting.
* Experience with business process analysis, scenario planning, and critical path analysis.
* Knowledge of global regulations and regulatory requirements; proficient with project management tools.
* Excellent verbal and written communication, strong strategic thinking, and ability to translate strategy into executable plans.
* Ability to drive decision-making and influence without formal authority; experience presenting to senior leadership and governance bodies.
* Up to 10% travel domestically and internationally.
Preferred:
* Experience leading submission teams and working with external partners.
* Project management certification.
* Regulatory certification (RAC).
* Proficiency with Microsoft Project.
Employment type: Full-time
Seniority level: Not Applicable
Job function: Legal
Industries: Pharmaceutical Manufacturing
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