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: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

All Job Posting Locations: Cambridge, Massachusetts, United States of America, Raritan, New Jersey, United States of America

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

We are searching for the best talent for a Director, Process Optimization Lead (Unified Regulatory Platform) to be located in Raritan, NJ or Cambridge, MA.

Purpose: The Director, Process Optimization Lead (Unified Regulatory Platform) is responsible for driving an effective model for the development of E2E processes which connect across GRA capabilities for the establishment and advancement of the new URP platform.

This role will focus on identifying opportunities for streamlining and standardizing regulatory processes, reducing cycle times, and improving overall efficiency. This role will take part in driving the definition and implementation of an E2E process management model across GRA capabilities, which is compatible and aligned with business data and technology solutions.

You will be responsible for:

* Develop and implement a global regulatory process strategy that aligns with overall business objectives. * Take part in driving the definition and implementation of an E2E process management model, including connectivity with partner organizations for shared process ownership (e.g., Clinical, Safety, Supply Chain), and reach alignment with key stakeholders on implementation. * Apply consistent process design methodologies/frameworks (e.g., six sigma, Lean, BPM) to identify opportunities for streamlining/standardizing regulatory processes, reducing cycle times, improving overall efficiency, and helping to align overlapping sub-processes across workflows. * Take part in driving timely formation of URP project teams with appropriate leadership, skillsets, and resources (internal and external as required) to deliver future state E2E processes per capability. Escalate and resolve issues with resource availability to URP Leadership. * Lead cross-functional teams to implement process development initiatives and monitor progress against goals and objectives, partnering with GRA Process Governance under the RODI organizaiton to identify, prioritize and sequence initiatives. * Collaborate with stakeholders to develop and implement process metrics and track progress against established benchmarks. Ensure engagement of all GRA functions and relevant partners in E2E process development activities and serve as a champion and spokesperson for the strategic importance of the work * Provide thought leadership on regulatory process development best practices and emerging trends. * Contribute to the management and development of a team of process development experts to support the implementation of process initiatives. * Partner within IT to ensure compatibility and alignment of the E2E process management model with the business data, the technology solutions, and the compliance framework. * Advocate for and ensure appropriate change management to drive sustainability of the E2E process management model, and to ensure that regulatory staff are equipped with the necessary skills and knowledge to support optimized processes.

Qualifications / Requirements:

Education: * Minimum of Bachelor’s degree in scientific or technical discipline, Regulatory Affairs, Life Sciences, or a related field * Advanced degree is preferred

Required: * Minimum of 10 years’ experience in the pharmaceutical or healthcare industry * Mastery within regulatory affairs and advanced understanding of R&D process development * Strong analytical skills and the ability to translate data into information, and strategies into actionable plans. * Experience leading strategic planning initiatives and managing complex projects. * Experience working in a matrixed global organization. * Excellent communication and collaboration skills. * Demonstrated ability to lead cross-functional teams * Travel up to 10-25% of the time (domestic and international), defined by business needs.

Preferred: * Background in process optimization and change management. * Experience with data visualization tools and business intelligence software. * Green Belt / Black Belt

The anticipated base pay range for this position in the US is $160,000 to $276,000.

The Company maintains highly competitive, performance-based compensation programs.  Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.  The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.  Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on August 19, 2025.  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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is : $160,000-$276,000

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits