Regulatory Affairs Manager
Our company is seeking a Regulatory Affairs Manager to join the Company.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.
- 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.