At a Glance
- Tasks: Lead regulatory projects and empower teams to deliver impactful medicines for immunological disorders.
- Company: Join Johnson & Johnson, a leader in innovative medicine with a patient-focused approach.
- Benefits: Inclusive work environment, competitive salary, and opportunities for professional growth.
- Other info: Work in a dynamic environment with excellent career advancement opportunities.
- Why this job: Make a real difference in patients' lives by developing transformational treatments.
- Qualifications: 7+ years in industry, strong project management skills, and knowledge of global regulations.
The predicted salary is between 70000 - 90000 € per year.
About 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.
Location
This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; Raritan, NJ; Cambridge, MA; La Jolla, CA; Beerse, Belgium; Leiden, Netherlands; High Wycombe, UK; Allschwil, Switzerland; or Cork, Ireland.
Purpose
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. RPMs will 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 Sr. Manager, RPM, will be deployed in support of JJIM’s most complex programs, called on to lead critical department initiatives and may represent the function with organizational leadership and in larger capability enhancement efforts at cross‑functional and organizational levels. This individual will be expected to provide coaching, education and mentoring to more junior staff and select team efforts, while driving continuous enhancement of RPM impact for the organization.
Principal 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 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.
- 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.
- Provide strong operational leadership to Regulatory and program teams, providing scenario and visualization support driving rapid and informed decision making.
- Support the Global Regulatory Team (GRT) in a manner that fosters and maintains a high‑performance team culture.
- Ensure coordination of critical regulatory information and team communications to ensure timely and accurate dissemination of the GRT strategy.
- Lead the operational execution of select marketing applications including clinical variations and pediatric submissions.
- Drive process improvements and embed best practices from across programs, TAs, and functions into supported teams.
- Act as operational owner of the Global Filing and Launch Strategy.
- 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.
- 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.
- Support and facilitate activity, resource, and cost planning across the R&D project portfolio.
Qualifications
- A minimum of a Bachelor’s degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs, or a related discipline.
- A minimum of 7 years’ experience of industry/business is required.
- A minimum of 3 years of experience in a Pharmaceutical, MedTech or comparable R&D area is required.
- Experience in strategic planning and development of regulatory strategy, and cross‑functional management of global regulatory submissions and processes (e.g., NDA, MAA) is required.
- Project management experience leading global regulatory teams in a matrix setting is required.
- Experience leading submission teams and working with external partners is preferred.
- Demonstrated experience conducting business process, scenario, and critical path analysis on complex projects.
- Knowledge of global regulations, guidelines, and regulatory requirements with in-depth knowledge/focus of FDA/EMA procedures is required.
- Proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required.
- Project management certification preferred.
- Regulatory certification (RAC) preferred.
- Proficiency with Microsoft Project is highly preferred.
Johnson & Johnson is an equal opportunity employer. We provide an inclusive work environment where each person is considered as an individual.
Senior Manager, Regulatory Program Management - Immunology employer: Johnson & Johnson
At Johnson & Johnson, we pride ourselves on being an exceptional employer, particularly for those in the Senior Manager, Regulatory Program Management role. Our inclusive work culture fosters collaboration and innovation, empowering employees to make a meaningful impact on global health while enjoying robust professional development opportunities. With locations across the globe, including Spring House, PA, and High Wycombe, UK, we offer a dynamic environment where you can thrive and contribute to pioneering advancements in immunology.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Regulatory Program Management - Immunology
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those working in regulatory affairs or immunology. Attend relevant events or webinars and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by researching the company and its recent projects. Understand their approach to regulatory challenges in immunology. This will help you tailor your answers and show that you're genuinely interested in contributing to their mission.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of a Senior Manager in Regulatory Program Management. Highlight your project management skills and any specific achievements that demonstrate your ability to lead teams and drive results.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team and making a difference in the field of immunology.
We think you need these skills to ace Senior Manager, Regulatory Program Management - Immunology
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Senior Manager role. Highlight your experience in regulatory affairs and project management, and show how your skills align with our mission in immunology.
Showcase Your Impact:We want to see how you've made a difference in your previous roles. Use specific examples to demonstrate how you've empowered teams or driven successful regulatory submissions. Numbers and outcomes speak volumes!
Be Clear and Concise:Keep your application straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key achievements are easy to spot. This helps us quickly understand your fit for the role.
Apply Through Our Website:Don’t forget to submit your application through our official website! It’s the best way for us to receive your details and ensures you’re considered for this exciting opportunity in our Immunology team.
How to prepare for a job interview at Johnson & Johnson
✨Know Your Regulatory Stuff
Make sure you brush up on global regulations, especially FDA and EMA procedures. Be ready to discuss how your experience aligns with the regulatory strategies mentioned in the job description. This shows you’re not just familiar with the basics but can also navigate complex regulatory landscapes.
✨Showcase Your Project Management Skills
Prepare examples of your project management experience, particularly in leading global regulatory teams. Use the STAR method (Situation, Task, Action, Result) to structure your responses, highlighting how you’ve driven projects forward and managed cross-functional teams effectively.
✨Demonstrate Your Leadership Style
As a Senior Manager, you’ll need to empower and mentor your team. Think about your leadership style and be ready to share specific instances where you’ve coached junior staff or led initiatives that fostered a high-performance culture. This will help interviewers see you as a potential leader in their organisation.
✨Be Ready for Scenario Questions
Expect questions that ask you to analyse scenarios or critical paths in complex projects. Prepare by thinking through past experiences where you had to identify risks and opportunities. This will demonstrate your analytical skills and ability to make informed decisions under pressure.
