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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function
Regulatory Affairs Group
Job Sub Function
Regulatory Product Submissions and Registration
Job Category
Professional
All Job Posting 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
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Raritan, NJ or Titusville, NJ or Horsham, PA - Requisition Number: R-061303
Allschwil, Switzerland - Requisition Number: R-062522
High Wycombe, United Kingdom - Requisition Number: R-062527
Beerse, Belgium or Warsaw, Poland - Requisition Number: R-062533
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
We are searching for the best talent for Manager, Regulatory Business Analyst for either Raritan, NJ or Titusville, NJ or Horsham, PA or Allschwil, Switzerland or High Wycombe, United Kingdom or Beerse, Belgium or Warsaw, Poland.
Purpose
The Manager, Regulatory Business Analyst will collaborate with business stakeholders and technical teams by analyzing, evaluating, and translating user requirements to identify and drive optimal solutions aligned with business outcomes. This position requires strong analytic thinking and creative problem-solving skills with the ability to imagine new possibilities, apply modern technologies and communicate effectively to business and technical teams. The incumbent will also be responsible for supporting system training, user acceptance testing, and engaging in continuous research and discovery to identify market trends in our competitive landscape, gather user feedback and proactively assess evolving business requirements.
Responsibilities
* Collaborating with business stakeholders and technical teams by analyzing, evaluating, and translating user requirements to drive optional solutions aligned with business outcomes.
* Translating user requirements into clear, concise, and accountable documentation including user personas, use cases, journey maps, and process flows.
* Developing user-friendly solutions using techniques grounded in agile and design thinking principles to uncover optimal workflows and user experiences with available technologies.
* Supporting ongoing enhancements to Regulatory platforms and systems by gathering feedback, assessing change requests, and helping prioritize feature development
* Partnering with business product leaders to translate product updates into business outcomes to enhance user experience and adoption
* Engaging in continuous discovery to identify new opportunities by gathering user feedback, analyzing market trends, and assessing emerging business needs
* Maintaining an understanding of the portfolio of Regulatory technical solutions
* Supporting user training, act as an ambassador of digital solutions, and partner with business product leads to ensure smooth launch and adoption.
* Collaborating with technical teams and users during UAT, validating business needs are met and identifying defects and/or gaps.
* Supporting the design of Regulatory end-to-end processes aligned to the defined business strategy using established GRA Process Office governance, standards, and methodologies.
* Supporting the business to establish efficiency, effectiveness, and experience KPIs for processes
Education
* Minimum of a Bachelor’s degree in Computer Science, Engineering, Biochemistry, Biological Sciences, Biology, or related discipline is required
* Master’s degree is preferred
Qualifications
* A minimum of 6 years relevant experience in the pharmaceutical, life sciences, or healthcare industry is required
* Demonstrated expertise in conducting business process analysis, problem framing, design thinking, and analytic techniques is required
* Creative problem-solving skills with a focus on feasibility assessments is required
* In-depth knowledge of Regulatory processes and global compliance standards (e.g, FDA, EMA, ICH) and technical solutions (e.g., RIM, Veeva, Calyx, etc.) is required
* Aptitude to stay current with industry trends related to solutions and stakeholder needs is required
* Proficiency in using agile tools and methodologies (e.g., Kanban, Scrum) is required
* Strong understanding of data integrity, compliance and validation is required
* Advanced knowledge of analytical tools (e.g., Tableau) is required
* Excellent verbal and written communication skills are required
* Sense of urgency to deliver results while balancing high-quality outcomes and an astute understanding of what constitutes “good enough.”
* Excellent partnerships skills to foster collaboration across organizational boundaries are required
* Action-oriented and inquisitive self-starter with ability to learn quickly and challenge status quo to deliver innovative solutions is required
* Demonstrated experience leading and managing cross-functional teams is required
* Big picture view to problem solving with attention to detail is required
* Ability to distill and communicate complex analyses in a clear, effective way to various stakeholders is required
* Demonstrates ability to lead with agility, champion a fail-fast and learning culture to enable rapid adaptation and deliver measurable outcomes is required
* Thrive in working independently and in a fast-paced, matrixed environment is required
* Develop and manage relationships with stakeholders and subject matter experts
* Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude
Other Desired Qualifications
* Strong ability to understand strategic business context and direction, anticipate needs and consider new possibilities is required
* Proven ability to conduct thorough market and competitive analysis, including data interpretation and trend forecasting is preferred
* Ability to manage UAT and system validation is preferred
* Experience in leading multiple, complex projects from inception to completion is preferred
* Experience assessing and evaluating novel technology solutions is preferred
* Project management certification or application of methodologies (e.g, Waterfall, Green Belt, Black Belt) is preferred
* Proficiency with productivity and collaboration tools (e.g. PowerBI, Power Automate, Generative AI tools, Mural)
Up to 10% travel required on as needed basis.
This job posting is anticipated to close on March 19, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Required Skills
Coaching, Compliance Management, Continuous Improvement, Design Thinking, Package and Labeling Regulations, Process Improvements, Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard Operating Procedure (SOP), Strategic Thinking, Sustainability, Sustainable Packaging, Technical Credibility, Transparency Reporting
Preferred Skills
Coaching, Compliance Management, Continuous Improvement, Design Thinking, Package and Labeling Regulations, Process Improvements, Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard Operating Procedure (SOP), Strategic Thinking, Sustainability, Sustainable Packaging, Technical Credibility, Transparency Reporting
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