Manager, Regulatory Affairs

Alternative Resources Company

Manager, Regulatory Affairs

Manager, Regulatory Affairs
  • 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.