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Regulatory Affairs Manager

Job Description

Edenbridge Pharmaceuticals is seeking a Regulatory Affairs Manager to join the Company at its Parsippany, NJ corporate office. The position will be responsible for coordinating and writing regulatory submissions for the Company. The successful candidate will:

  • Compose and coordinate regulatory submissions for the Company including original ANDAs, supplements, CBE-30s, annual reports, SPLs, PADERs, and 505(b)(2) filings.
  • Ensure compliance with post-approval regulatory filing deadlines and oversee lifecycle management of regulatory submissions.
  • Maintain drug product labeling components and drug listings for commercial products.
  • Review documents received from CMOs for completeness.
  • Review change controls for completeness and accuracy and assess the impact on current regulatory filings.
  • Keep abreast of regulatory knowledge and initiatives including ICH, USP, and other regulatory intelligence sources.

Qualifications

  • Bachelor’s degree with 5+ years work experience in US FDA regulated pharmaceutical development and manufacturing.
  • Experience with US FDA ANDA submissions in eCTD format required.
  • Strong background in chemistry, manufacturing, and controls documentation required.
  • Self-starter who can be effective with minimal supervision.
  • Previous experience working in a virtual or small company environment strongly preferred.
  • Excellent communication and interpersonal skills across all levels of the Company.
  • Strong writing skills consistent with the ability to prepare concise, timely, and accurate reports.

Qualified candidates should submit their resumes directly to careers2@edenbridgepharma.com.