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Senior Regulatory Affairs Associate - REMs & Labeling

Title: Senior Regulatory Affairs Associate - REMS & Labeling

Location: Princeton, NJ

Duration: 6-12 Months (Contract-to-Hire)

Rate: To be discussed…

This is position is located in Princeton, NJ. As a Senior Regulatory Affairs Associate - REMS & Labeling, you'll work closely with Regulatory Affairs Manager and Regulatory Affairs Associates to ensure the compliance and completion of assigned activities and provide regulatory strategic input and compliance with FDA regulations, guidance, and applicable industry guidelines to internal and external stakeholders, and ensure the implementation.

Areas of Responsibility:

  • Participate in daily meetings with internal and external stakeholders and coordinate with REMS Program Management Offices (PMOs), REMS administrators, other sponsor companies, vendors, and the FDA to develop new REMS programs and modify existing REMS programs
  • Act as the Single Point of Contact (SPOC), represent the company in REMS meetings, and make decisions on behalf of the company in shared REMS programs
  • Review REMS documents and materials for accuracy and ensure compliance with current regulations
  • Respond to FDA inquiries on REMS and labeling requirements
  • Prepare REMS and labeling pre-approval and post-approval supplements, amendments, and/or correspondences
  • Create, review, and approve labeling materials/artwork for prescription and over-the-counter (OTC) products
  • Review and implement Safety Labeling Changes and Reference Listed Drug (RLD) labeling updates
  • Review promotional materials and submit to the FDA for review, as necessary.
  • Initiate change control process and coordinate with other departments to ensure timely implementation of revised labeling.
  • Prepare, review, compile and submit eCTD submissions and SPLs.
  • Maintain regulatory databases by regularly updating information for completeness and ensuring correctness.
  • Review and prepare RA assessments of change control for completeness and accuracy under RA Manager's supervision
  • Perform other duties as assigned.

Requirements:

  • Bachelor Degree in Sciences, or related degree and 3+ years' experience in Regulatory Affairs in REMS and Labeling.
  • Working knowledge of ANDA, and post-approval submission requirements and guidelines as applicable to REMS and Labeling
  • Must be highly organized and have the ability to meet critical timelines. Able to work as part of a team.
  • Detail oriented with strong communication and organizational skills with the ability to multi-task.
  • Excellent regulatory, technical, and problems solving skills
  • Excellent knowledge of electronic submission guidance documents and regulations
  • Working knowledge of ANDA, and post-approval submission requirements and guidelines.
  • Demonstrate the ability to coordinate submissions independently in a time intensive situation
  • Good computer skills. - Microsoft office, adobe professional, etc. Experience using eCTD submission and SPL software.

Sthree US is acting as an Employment Business in relation to this vacancy.