Regulatory Affairs Senior Manager

Job Title: Regulatory Affairs Senior Manager
Location: Warren, NJ
Type: 6-month Contract
Compensation: $73.00 - $76.00
Contractor Work Model: Hybrid – onsite and remote
Hours: 8am-5pm

Overview
The purpose of this role is to execute OTC regulatory activities for new products registrations and life-cycle maintenance for the portfolio of products defined by the US Business Units.

Responsibilities

• Ensure cross-portfolio aligned regulatory strategies to deliver timely approvals for US submissions and OTC Monograph product launches.
• Develop and implement regulatory strategies and documents for new product launches and ongoing product maintenance aligned with regulatory requirements.
• Support processes related to regulatory labeling, artwork review, and compliance with local regulations.
• Assist in the development of claims, advertising, and promotional materials ensuring regulatory compliance and risk management.
• Prepare registration files, briefing documents, supplements, annual reports, and respond to agency questions.
• Engage with US regulatory agencies through meetings and teleconferences to facilitate product registration activities.
• Interact with regulatory agencies to address questions and provide necessary documentation.
• Support quality and process improvements within the US portfolio and provide cross-portfolio support as needed.
• Manage compliance within specified activity streams, ensuring adherence to company expectations.
• Provide guidance on US-specific regulatory activities and internal processes.
• Identify potential regulatory risks and manage the impact of regulatory changes within scope.
• Maintain current knowledge of regulatory requirements and developments in technical trends.
• Collaborate with colleagues and stakeholders to identify opportunities, solve challenges, and lead improvement initiatives.

• Bachelor’s Degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, Medicine, or related field
• Minimum 8 years of experience in regulatory affairs
• Experience with FDA applications, OTC monograph products, and CMC (Chemistry, Manufacturing, and Controls)
• Proficient understanding of US FDA regulations
• Strong communication, stakeholder management, and team collaboration skills
• Ability to prioritize and manage high-complexity projects effectively
• Experience leading regulatory activities for new product launches
• Proven leadership in managing cross-functional teams or projects

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.

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