Regulatory Affairs Associate job at Solomon Page Florham Park, NJ, US

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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