Overview
Join to apply for the Manager, Regulatory Program Manager - Immunology role at Johnson & Johnson Innovative Medicine.
We are searching for the best talent for Manager, Regulatory Program Manager – Immunology, to be located in Allschwil, Switzerland. This is a hybrid position and requires you to be onsite 3 days a week.
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.
About Immunology
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.
Job Details
* Location: Allschwil, Basel-Country, Switzerland (Hybrid: onsite 3 days a week)
* Job Function: Project/Program Management Group
* Job Sub Function: R&D Project Management
* Job Category: Professional
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 programs, business, and patients worldwide.
* Translate regulatory requirements and strategy into an executable plan with clear priorities, proactively identify and mitigate risks, and exploit opportunities for acceleration (e.g., MSP project plan, risk and opportunity playbooks).
* Lead operations with Global Regulatory Team (GRT), including visibility/management of worldwide submissions, optimization of global filing and launch sequencing, pre/post-submission activities, and preparation for health authority meetings and major regulatory milestones.
* Provide strong operational leadership to Regulatory and program teams, offering scenario and visualization support to drive rapid, informed decision making.
* Support the GRT to maintain a high-performance team culture, facilitating GRT, Submission Working Group, Rapid Response Team meetings, and similar as required.
* Coordinate critical regulatory information and team communications to ensure timely dissemination of the GRT strategy and status, including co-development partners and external partners as required.
* Lead the operational execution of select marketing applications including clinical variations and Pediatric submissions, aligning Regulatory and submission strategies and developing detailed submission plans.
* Drive process improvements and embed best practices across programs, TA’s and functions into supported teams.
* Work across functions to establish processes and innovative methods that improve overall delivery.
* Build RPM value proposition through delivery refinement and enable enhanced capabilities and impact.
* Mentor and coach other RPMs and team members.
* Support budgeting and forecasting processes and reporting tools to build and maintain regulatory components and health authority budget within the overall project plan in Planisware.
* Assist with activity, resource and cost planning across the R&D project portfolio as required.
Qualifications / Requirements
* Bachelor’s degree required; life sciences, regulatory affairs, or related discipline preferred; advanced degree preferred.
* Minimum 5 years of industry/business experience.
* Minimum 3 years of experience in Pharmaceutical, MedTech or related R&D area.
* Experience in strategic planning and development of regulatory strategy, and cross-functional management of global regulatory submissions (e.g., NDA, MAA) across drug development phases.
* Understanding of Global Regulatory Affairs processes.
* Project management experience leading global regulatory teams in a matrix setting.
* Experience with business processes, scenario, and critical path analysis.
* Knowledge of global regulations and regulatory requirements; proficiency with project management standards and tools.
* Excellent verbal and written communication skills; strong innovative and strategic thinking skills.
* Ability to translate strategy into clear, executable action plans and influence decisions at all levels; willingness to travel up to 10% domestically and internationally.
Preferred
* Experience leading submission teams and working with external partners.
* Project management certification.
* Regulatory certification (RAC).
* Proficiency with Microsoft Project.
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