Regulatory Affairs Senior Associate

Job Title: Regulatory Affairs Senior Associate

Location: Warren, NJ

Type: 6-month Contract

Compensation: $49.15 hourly

Contractor Work Model: Hybrid – onsite and remote

Hours: 8am-5PM, 40 hours per week

Overview

The purpose of this role is to execute OTC regulatory activities for new products registrations. 

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 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.

• 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 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 highly complex projects.
• Experience leading end-to-end regulatory processes in new product launches.
• Knowledge of US regulatory framework for OTC drugs and OTC medical devices (preferred).
• Ability to ensure compliance standards and KPIs are met.
• Minimum 2 years of experience in regulatory affairs.
• Strong technical knowledge and attention to detail.
• Excellent written and verbal communication skills.
• Ability to interact at multiple organizational levels.

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.

#M-



Ref: #568-Clinical