Job Description

Our client is looking to fill the role of Regulatory Affairs Associate. This role is hybrid and based out Livingston, NJ. 

Responsibilities:

• Stay up to date with current regulatory requirements and industry guidelines.
• Support the development, review, and submission of regulatory documents, including advertising and promotional materials, meeting packages, NDAs, annual reports, PADERs, amendments, and supplements to ensure accuracy and compliance.
• Assist in the electronic publishing of submissions using the eCTD format.
• Coordinate and track drug labeling updates, including registration and product listings.
• Maintain and monitor FDA communications, including submission and report tracking logs.
• Oversee purchase order creation and assist with onboarding new vendors.
• Ensure timely renewal and maintenance of state distribution licenses.
• Provide general administrative support for various regulatory activities.

Required Qualifications:

• Bachelor’s degree in Chemistry or Biology required; PharmD preferred.
• Fluency in English is required; Spanish proficiency is a plus.
• Minimum of 1 year of relevant experience.
• Excellent written and verbal communication skills
• High attention to detail and strong analytical capabilities

Clinical Resource Network Distinction   

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve. 

About CRN  

Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn. 

Opportunity Awaits. 

Job Tags

Hourly pay, Full time, Contract work,

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