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Regulatory Affairs Specialist

2 months ago

Reston, Virginia, United States Barrington James Full time

Senior Regulatory Associate - Hybrid Role

Barrington James is partnering with a global commercial pharmaceutical company to find a talented Senior Regulatory Associate to join their team. This is a hybrid role based in New Jersey, offering a great opportunity to work on diverse projects.

In this role, you will be the Regulatory lead for submission planning and strategy for development projects and existing FDA-approved products. You will be expected to prepare high-quality ANDA submissions (including amendments, supplements, and Annual Reports) with the support and oversight of the Senior Manager/Associate Director of Regulatory Affairs.

Key Responsibilities:

  • Act as the Regulatory Affairs lead on assigned projects, ensuring the completion, accuracy, and content of eCTD submissions (ANDAs, Supplements, Amendments, and Annual Reports).
  • Maintain and update senior Regulatory Affairs management on critical project developments and their potential impact on regulatory submissions, highlighting any challenges or issues that might arise during an FDA review.
  • Collaborate with different stakeholders across the company and procure documentation required for regulatory submissions, ensuring that departmental timelines are met.
  • Support the creation and review of technical documents for accuracy and acceptability for use in new ANDAs, Amendments, Supplements, Annual Reports, and other required FDA filings to ensure high-quality submissions and prompt approvals from the FDA.
  • Review and approve change controls and assess their impact on the business based on an advanced understanding of regulatory guidelines and applicable FDA laws.

Requirements and Qualifications:

  • Education: Minimum of a bachelor's degree in a life science, pharmacy-related curriculum, and/or an advanced degree related to Manufacturing, Chemical, Pharmaceutical, or Biological Sciences. (RAC Certification is a plus)
  • Experience: 2+ years in the generic pharmaceutical industry, ideally in Regulatory Affairs.
  • Specific Knowledge: General practices in Regulatory Affairs for generic drugs and FDA guidelines.
  • Travel: 5% (potential overseas travel to visit manufacturing sites/CMOs or CROs).

This is a fantastic opportunity to work with a global commercial pharmaceutical company and contribute to the development of generic drugs. If you have a strong background in Regulatory Affairs and are looking for a new challenge, please apply today.