Sr. Regulatory Affairs Professional, Global TA

Job Description We are searching for the best talent for a Sr. Regulatory Affairs Professional, Global TA located in Spring House, PA, Raritan or Titusville, NJ. The Global Regulatory Affairs (GRA) team seeks a high‑energy, inventive, self‑starter passionate about advancing a career in healthcare. As a Sr. Regulatory Affairs Professional, Global TA , you will support drug development programs and marketed products across multiple therapeutic areas, gaining broad regulatory experience through a flexible rotational model. Through hands‑on, real‑world experiences you will work on projects that improve leadership, problem solving, and creative thinking skills, while acquiring the business savvy required in a fast‑paced regulatory environment. Responsibilities Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements and project‑specific issues. 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 needed. Ensure timely responses to Regulatory Agency queries, maintaining consistency with the regulatory strategy. Work cross‑functionally, coordinate between departments, and lead team meetings as appropriate. Advise the team on required documents and submission strategies. Review clinical trial plans, protocols, and submission plans to ensure alignment with regulatory requirements. Support the development and improvement of processes related to regulatory submissions. Provide regulatory input for and follow‑up to inspections, audits, litigation support, and product complaints. Stay current on approvals in assigned therapeutic areas and be knowledgeable of applicable laws, guidelines, and requirements. May interact with Health Authorities regarding program‑specific issues and serve as secondary Health Authority point‑of‑contact to represent J&J/Janssen externally with some supervision. Qualifications & Requirements Education: Bachelor’s degree in a scientific or equivalent discipline + 6 years of experience in academia or industry OR Pharm D/PhD + 2 years of experience OR Master’s + 3 years of experience (required). Understanding of the drug development process. Preferred Skills Previous experience in a health‑regulated industry. Understanding of regulatory submission and approval processes, including US and EMA guidelines. Relevant regulatory affairs experience in pharmaceutical/biotech. Experience responding to Health Authority requests and managing interactions. Diverse therapeutic area experience. Experience within a cross‑functional team environment as an individual contributor and decision maker. Proactive issue anticipation and judgment in developing solutions. Ability to influence or persuade others within immediate responsibility. Project management skills and ability to prioritize multiple projects simultaneously. Strong interpersonal and communication skills. Compensation Base pay range: $109,000.00 – $174,800.00. Benefits Vacation – 120 hours per calendar year. Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents. 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 birth/adoption/foster care. Bereavement leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year. Caregiver leave – 80 hours in a 52‑week rolling period + 10 days. Volunteer leave – 32 hours per calendar year. Military spouse time‑off – 80 hours per calendar year. 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)). #J-18808-Ljbffr Johnson & Johnson Innovative Medicine