USA_Regulatory Associate - Level 3

Job Title: USA_Regulatory Associate - Level 3 Location: Warren, NJ Type: 12-month contract Compensation: $49.15 hourly Work Model: Hybrid - 2-3 days onsite Hours: 8am-5PM Overview The purpose of this role is to execute OTC regulatory activities for new product registrations and life‑cycle. Maintenance for the portfolio of products defined by the US Business Units. Responsibilities Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA). Develop regulatory strategies and documents for new product launches and maintenance of current products aligned with the regulations. Develop regulatory label for OTC products, review claims and copy. Participate in the review of promotional materials. Support end-to-end regulatory compliance of products in remit. Apply system and procedure updates to maintain up-to-date technical product records. Identify and participate in process improvements within US Regulatory Affairs. Interact with colleagues in other global functions to support global programs. Effectively communicate regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develop up-to-date knowledge of guidelines and regulatory requirements, as well as technical trends. Requirements Bachelor’s degree in Pharmaceutical or Life Sciences or equivalent regulatory experience. 2-4 years’ experience in regulatory affairs including chemistry, manufacturing and controls, and OTC experience, preferably within a CPG/Consumer Healthcare/Pharma related industry. Experience and knowledge in Quality, product development and manufacturing areas. Experience working on FDA applications, OTC monograph products, chemistry, manufacturing and controls. Proficient knowledge in US FDA regulations. Excellent communication skills, stakeholder management, and ability to work in multidisciplinary teams. Ability to manage and prioritize projects of high complexity. Experience leading end-to-end regulatory processes in new product launches. Additional Preferred Qualifications: knowledge of US regulatory framework for OTC drugs and devices, ensuring compliance standards, and regulatory lifecycle expertise. Minimum 2 years of experience in regulatory affairs. Competencies include agility, attention to detail, strong written and verbal communication skills, evidence-based decision making, and risk evaluation. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #J-18808-Ljbffr System One