Johnson Johnson is recruiting for a Regulatory Program Manager, Immunology.
This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; La Jolla, CA; Beerse, Belgium; Leiden, Netherlands; High Wycombe, UK; Basel, Switzerland; or Cork, Ireland.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.
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.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.Key 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, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration.Lead operations with Global Regulatory Team (GRT), including management of worldwide submissions and driving processes to optimize global filing and launch sequencing.Provide strong operational leadership to Regulatory and program teams, fostering impactful innovation.Ensure coordination of critical regulatory information and team communications.Lead operational execution of select marketing applications, developing clear and detailed submission plans.Drive process improvements and embed best practices from across programs.Build RPM value proposition through continuous refinement of delivery.Serve as a mentor and coach to other RPMs and team members.Qualifications:Education: A minimum of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs, or a related discipline.
Advanced degree preferred.Experience and Skills:A minimum of 5 years of industry/business experience is required.A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable RD area is required.Experience in strategic planning and development of regulatory strategy is required.Demonstrated understanding of Global Regulatory Affairs processes is required.Project management experience leading global regulatory teams in a matrix setting is required.Knowledge of global regulations, guidelines and regulatory requirements is required.Proficiency with Microsoft Project is highly preferred.Must have excellent verbal and written communication skills.This position will require up to 10% domestic and international travel.The anticipated base pay range for this position is $ to $.
The Company maintains highly competitive, performance-based compensation programs.For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits #J-18808-Ljbffr