Johnson & Johnson Innovative Medicine is recruiting for a Senior RA Professional Global, Oncology. The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor. This position can be located in Spring House, PA; Horsham, PA; Titusville, NJ; and Raritan, NJ. Any other Johnson & Johnson campus locations/remote options, could be considered for the right candidate. 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/.   For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong. This position will support the Regional Regulatory Leaders and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area. Key Responsibilities: + Participate in global regulatory team meetings and provide advice the applicable regulatory requirements, project-specific regulatory issues. + Build an understanding of the regional regulatory environment (relevant laws, regulations, guidance and competitive landscape) for assigned products. + Assist in strategy development by researching regulatory and medical information in preparing submissions to North American Health Authorities (HAs). + Assist in the preparation of HA meetings and act as back-up for contact with HA as needed. + Ensure responses to HA queries are made in a timely manner, and that content is consistent with the regulatory strategy. + Provide regulatory support throughout registration process and life-cycle management. + Work cross-functionally and lead team meetings as appropriate. + Review development plans, protocols and submission plans, ensuring alignment with regulatory requirements. + Support the development and improvement of processes related to regulatory submissions. + Stay on top of current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidances and requirements related to those areas. **Qualifications** Education: + Bachelor’s Degree in a scientific or equivalent subject area with 6 years of relevant industry experience or Master’s degree with 4 years of relevant experience, or PharmD/Ph.D. with 2 years of relevant experience is required. Experience and Skills: Required: + Previous regulated health industry experience. + Solid understanding of the drug development process and regulatory submission and approval processes. + Knowledge of US and/or other global HA guidelines and practices in the regulatory environment. + Ability to work effectively within a cross-functional team and as an individual contributor. + Strong Project management, oral & written communication skills, organization and multi-tasking skills. + Strong interpersonal and time management skills + Demonstrated ability of critical thinking and contingency planning skills with respect to organizational or program objectives. + Effective critical thinking, including problem solving and goal setting for improved efficiencies. + 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). + Ability to work successfully in a matrixed environment. + Regulatory experience with products in early and late development stages. + Experience responding to Health Authority requests, handling HA interactions, and lifecycle management of regulatory applications. Preferred: + Therapeutic area experience in oncology is highly desired. Experience with companion diagnostics, combination products and/or biomarker development, or medical device is beneficial. Other: + Proactively anticipates issues; exercises judgment in developing new approaches/solutions and solving problems. + Influences or persuades others within area of immediate responsibility, scope and level to accept new insights, practices and approaches + May have interaction with internal and external colleagues with coordination between departments. + May represent J&J or company externally with some degree of supervision. + This position may require less than 10% travel. Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability. The anticipated base pay range for this position is 105000 to 169050. 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)). + 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 of Work, Personal and Family Time - up to 40 hours per calendar year + Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.