Manager, Regulatory Program Manager

vor 3 Wochen


Allschwil, Schweiz Johnson & Johnson Innovative Medicine Vollzeit

Manager, Regulatory Program Manager - Immunology Join to apply for the Manager, Regulatory Program Manager - Immunology role at Johnson & Johnson Innovative Medicine 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 Locations Allschwil, Basel-Country, Switzerland 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 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. Learn more at https://www.jnj.com/innovative-medicine Multiple Countries Posting This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. 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, your application will be considered as a single submission. Role Summary This 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. The Manager will serve as the primary project management point of contact to ensure regulatory functional plans are aligned with compound/program objectives and commitments. Responsibilities Empower teams to deliver the highest possible impact. Translate regulatory requirements and strategy into executable plans and anticipate risks. Lead operations with Global Regulatory Team, including global filing and launch sequencing. Provide strong operational leadership to Regulatory and program teams. Support the Global Regulatory Team in fostering a high-performance team culture. Coordinate critical regulatory information and team communications. Lead the operational execution of selected marketing applications. Drive process improvements and embed best practices. Work across functions and organizational boundaries to improve delivery. Build RPM value proposition through continuous refinement. Serve as a mentor and coach to other RPMs and team members. Maintain regulatory budgeting and forecasting and activity planning. Qualifications Minimum of a Bachelor’s degree in Life Sciences, Business Management, Regulatory Affairs or related. Minimum of 5 years of industry/business experience. Minimum of 3 years in Pharmaceutical, MedTech, or comparable R&D area. Experience in strategic planning and regulatory strategy development. Demonstrated understanding of Global Regulatory Affairs processes. Project management experience leading global regulatory teams. Experience conducting business processes, scenario, and critical path analysis. Knowledge of global regulations, guidelines, and requirements. Proficiency in project management standards, planning, and visualization tools. Excellent verbal and written communication skills. Strong innovative and strategic thinking skills. Experience expediting team decision-making. Experience resolving controversy and influencing teams without formal authority. Experience influencing decision-making at all levels and representing project teams with senior leadership. Will require up to 10% domestic and international travel. Preferred Experience leading submission teams and working with external partners. Project management certification. Regulatory certification (RAC). Proficiency with Microsoft Project. Required Skills Agility Jumps, Business Alignment, Coaching, Collaborating, Continuous Improvement, Operational Excellence, Performance Measurement, Process Control, Process Improvements, Project Management Methodology (PMM), Project Management Office (PMO), Project Reporting, Project Scheduling, Quality Control (QC), Research and Development, Tactical Planning, Technical Credibility Seniority Level Not Applicable Employment Type Full-time Job Function Legal Industries Pharmaceutical Manufacturing Get notified about new Regulatory Manager jobs in Allschwil, Basel-Country, Switzerland. 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