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Senior Manager/Associate Director of Regulatory Affairs

Job Description

Edenbridge Pharmaceuticals is seeking a Senior Manager or Associate Director of Regulatory Affairs to join the Company at its Parsippany, NJ corporate office. The position will be responsible for coordinating, writing and reviewing all regulatory submissions for the Company. This is an opportunity for an experienced individual to join a growing specialty pharmaceutical company and work directly with the senior management of the Company. The successful candidate will:

  • Compose, coordinate and review all regulatory submissions of the company including original ANDAs, supplements, CBE-30s, annual reports, SPLs, PADERs and 505(b)(2) filings.
  • Ensure compliance with all post-approval regulatory filing deadlines and oversee life cycle management of regulatory submissions.
  • Serve as lead regulatory contact to all development partners, CMOs and regulatory consultants.
  • Maintain drug product labeling components for all commercial products.
  • Serve as the regulatory representative on cross-functional teams supporting products throughout all stages of development and commercialization.
  • Ensure regulatory and cross-functional project strategies and submission timelines are in alignment.
  • Develop and track regulatory project timelines that incorporate all submission requirements including CMC, clinical, and labeling functions.
  • Evaluate and approve proposed changes to approved products for potential regulatory impact.
  • Author and review departmental SOPs, as well as any other additional SOPs that may impact regulatory affairs.
  • Qualifications

  • Bachelor's degree with 7+ years work experience in US FDA regulated pharmaceutical development and manufacturing.
  • Extensive 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 careers@edenbridgepharma.com.