draft banner

Regulatory Affairs, Manager

Job Description

Edenbridge Pharmaceuticals is seeking a Manager of Regulatory Affairs 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 of 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 life cycle 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 preferred.
  • Excellent organizational and time management skills, as well as communication and interpersonal skills across all levels of the Company.
  • Self-starter who can be effective with minimal supervision.
  • Previous experience working in a small-to-midsize company environment.
  • Excellent writing skills consistent with the ability to prepare concise, timely and accurate reports.

Qualified candidates should submit their resumes directly to careers4@edenbridgepharma.com.