Associate Director, Regulatory Affairs, North American Regional Leader

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.comAs 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 GroupJob Sub Function: Regulatory AffairsJob Category:ProfessionalAll Job Posting Locations:Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of AmericaJob Description:About Innovative MedicineOur 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 We are searching for the best talent for an Associate Director, Regulatory Affairs, North American Regional Leader (NARL) to be located in Spring House, PA or Raritan, NJ.Purpose: The Associate Director, Regulatory Affairs, North American Regional Leader, is responsible for North American and global regulatory strategies for select projects spanning the oncology therapeutic area. This role supports the initiatives for the Interventional Oncology group (INTO). The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor.You will be responsible for: Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs & supplements.Serve as primary point of contact for US FDA.Lead the regulatory response team for FDA and Health Canada questions.Key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.Manage routine maintenance submissions, coordinate NA post-approval commitments, provide input and review submission documents, as well as approves submissions before dispatching to regulatory authorities.Contributes to the development of the USPI, lead the development of NA labelling negotiation strategies, and development of supporting documentation for labelling, as well as reviews FDA and Health Canada labelling to ensure consistency with the CCDS and ensure that annotations are complete and correct.Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.Collaborate with cross-functional submission delivery teams.Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members.Ability to flex across different product types (pharma, devices, combo products).Intellectual curiosity and ability/flexibility in learning new things and working in novel areas with limited regulatory precedence. This role will include an opportunity to flex across different product types (pharma, devices, combo products).Qualifications/Requirements:Minimum of a Bachelor’s degree in scientific or equivalent disciplineBachelor’s degree plus 8+ years relevant experience OR;Master’s degree/ PharmD plus 6+ years relevant experience, OR;PhD plus 4+ years relevant experienceRelevant regulatory experience and understanding of clinical drug development, working with US FDA and global regulatory health authoritiesExperience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactionsExperience in lifecycle management of IND/NDA and other regulatory submissionsDemonstrated experience in critically reviewing and compiling regulatory documents is requiredPreferred Skills and Experience:Oncology experience highly preferred; diverse therapeutic area experience; Experience with companion diagnostics, combination products and/or biomarker development, or medical device is beneficialProven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organizationThe ability to effectively prioritize assignments for multiple products and projects simultaneouslyStrong interpersonal and communication skillsExperience people management/coaching/mentoring is preferredLeadership capabilities and ability to work successfully in a matrixed environmentExercises strong organizational and time management skillsExercises independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutionsDemonstrated ability of strategic thinking and contingency planning with respect corporate objectivesEffective critical thinking including problem solving and goal setting for improved efficienciesStrong collaboration skills, including effective communication and conflict resolution skillsMay cultivate and leverage strategic networks and partnerships10% domestic travel and potential international travel maybe required for this position#LI-HybridJohnson & 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 , internal employees contact AskGS to be directed to your accommodation resource.Required Skills:Preferred Skills:Analytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical CredibilityThe anticipated base pay range for this position is :$137,000.00 - $235,750.00Additional Description for Pay Transparency: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 yearSick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - Spring House, Pennsylvania, United States of America; Raritan, New Jersey, United States of AmericaType: Full time