Sr. Regulatory Affairs Professional, Global TA

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 America, Titusville, New Jersey, 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 are searching for the best talent for a Sr. Regulatory Affairs Professional, Global TA​, located in Spring House, PA, Raritan or Titusville, NJ.Purpose: Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who is passionate about advancing their career in healthcare. GRA is a key strategic partner supporting global R&D initiatives at Johnson & Johnson Innovative Medicine. As a Sr. Regulatory Affairs Professional, Global TA you will support drug development programs as well as marketed products across multiple therapeutic areas. You will gain broad and diverse regulatory experience supporting compounds in early to late drug development as well as life-cycle activities for approved products in our portfolio via a flexible rotational model geared towards addressing business needs and individual career-development goals.Through hands-on, real-world experiences, you will work on projects that improve your leadership, problem solving, and creative thinking skills. Furthermore, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.You will be responsible for:Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as neededEnsure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategyWork cross-functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriateAdvise team in required documents and submission strategiesReview clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirementsSupport the development and improvement of processes related to regulatory submissionsProvide regulatory input for and follow-up to inspections, audits, litigation support, and product complaintsStay on top of current and pending approvals in assigned therapeutic areas and is knowledgeable of laws, guidelines and requirements related to those areas.May interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact to represent J&J/Janssen externally with some degree of supervisionQualifications / Requirements:Education: Bachelor’s degree in a scientific or equivalent discipline + 6 years experience in academia or industry OR Pharm D/PhD + 2 years experience OR Masters +3 years of experience is required.Experience and Skills Required: Understanding of the drug development process.Preferred:Previous experience in a health regulated industryUnderstanding of regulatory submission and approval process and applicable US and EMA regulatory guidelinesRelevant regulatory affairs experience in pharmaceutical/biotechExperience responding to HA requests, managing HA interactions, and life cycle management applicationsDiverse therapeutic area experienceExperience within a cross-functional team environment as an individual contributor and decision makerProactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issuesInfluences or persuades others within area of immediate responsibility, scope, and level to accept new ideas, practices and approachesSkilled at project managing and effectively prioritizing assignments for multiple projects simultaneouslyStrong interpersonal and communication skills#LI-HybridRequired Skills:Preferred Skills:Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic ThinkingThe anticipated base pay range for this position is :$109,000.00 - $174,800.00Additional 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)).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: - Raritan, New Jersey, United States of America; Titusville, New Jersey, United States of America; Spring House, Pennsylvania, United States of AmericaType: Full time