Regulatory Affairs Manager

Job Description

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.

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.