Senior Manager, Regulatory Affairs Business Outcomes Delivery

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:

Spring House, Pennsylvania, 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

Johnson & Johnson Innovative Medicine R&D is recruiting for a  Senior Manager, Regulatory Affairs Business Outcomes Delivery.  This position is a hybrid role and will be located in Spring House, PA. Please Note: An internal pre-identified candidate for consideration has been identified.  However, all applications will be considered.

The Senior Manager, Regulatory Affairs Business Outcomes Delivery will have global responsibilities for overseeing the development, implementation, and continuous improvement of digital products that streamline interactions with health authorities.  This role will set the product vision, roadmap and objectives and key results (OKRs) with the Technical Product Leader for health authority query solutions, aligning with business objectives and regulatory mandates.  This role offers the opportunity to lead innovative initiatives that transform how health authority queries are managed, leveraging cutting-edge technology to support regulatory excellence and business growth.

Principal Responsibilities:

• Support the delivery of vision, strategy, and OKRs for development, implementation, and continuous improvement of digital products that streamline interactions with health authorities.

• Advance and maintain health authority interactions system platform and associated technologies.

• Collaborate with cross-functional teams including technical owner, business owner, and subject matter experts (SMEs) to gather requirements and prioritize features.

• Translate business needs into linguistic requirements and acceptance criteria.

• Ensure alignment of strategy with an outcome-focused roadmap.

• Implement efforts to drive adoption and benefits tracking.

• Analyze current workflows across to identify bottlenecks, inefficiencies, and gaps.

• Play supportive role in process mapping, standardization, and optimization efforts to drive operational efficiency and quality.

• Facilitate learning sessions to foster collaboration and promote a culture of continuous improvement.

• Partner closely with business users/subject matter experts, and other stakeholders to harmonize translation management processes and share best practices.

• Collaborate with cross-functional teams including technical owner, business owner, and SMEs to gather requirements and prioritize features.

• Work with sponsors and business leaders to align on product value and stakeholder engagement efforts.

• Partner with the Business Analyst to craft clear, testable requirements.

• Monitor product performance, gather feedback from stakeholders, and prioritize backlog by impact; define acceptance criteria with the Business Analyst to maximize impact.

• Drive adoption and benefits tracking with the Business Change Manager and Business Project Manager.

Qualifications:

• A minimum of a Bachelor’s degree in Regulatory Affairs, Life Sciences, or a related scientific or technical discipline is required.

• A minimum of 8 years of experience in the pharmaceutical or healthcare industry is required.

• A minimum of 3 years of experience in regulatory operations or a Good Practice (GxP) environment is required.

• Strong Regulatory Affairs expertise, with advanced understanding of related functions within and outside of Regulatory Affairs is required.

• Experience with audit and inspection readiness is required.

• Experience leading strategic product initiatives and managing complex projects is required.

• Team leadership experience is required.

• Experience mentoring or training peers is preferred.

• Knowledge of artificial intelligence, generative authoring, and automation tools is preferred.

• Project management certification (e.g., PMP) is preferred.

• Must have excellent communication and interpersonal skills.

• Must be detail-oriented with strong analytical and strategic problem-solving skills.

• Must have strong stakeholder management skills.

• The ability to translate data into information, and strategies into actionable plans is required.

• The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.

• Minimal travel is required.

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

 

 

Required Skills:

 

 

Preferred Skills:

Compliance Management, Design Thinking, Organizing, Package and Labeling Regulations, Process Improvements, Product Lifecycle Management (PLM), Product Packaging Design, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Standard Operating Procedure (SOP), Sustainability, Sustainable Packaging, Tactical Planning, Technical Credibility, Transparency Reporting