Regulatory Affairs Senior Associate

System One

📍 Warren, NJ, United States

Full-time other-general

Job Description

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 ...
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