Regulatory Affairs Associate III

Role Summary

Regulatory Affairs Associate III responsible for coordinating regulatory submissions (PINDs, INDs, NDAs, ANDAs), reviewing and compiling documentation, and assisting in regulatory strategy for assigned R&D projects, with oversight from management. Requires familiarity with US FDA and ICH guidelines and the ability to work with limited supervision.

Responsibilities

• Review change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make appropriate regulatory determinations.
• Write, review and compile documentation and data necessary for submission of assigned PINDs, INDs, ANDAs and NDAs with limited supervision from manager.
• Write, review and compile documentation necessary for responses to FDA Deficiency letters.
• Write, review and compile documentation and data for correspondences and post-approval supplements.
• Review applicable revised and new regulations and guidance distributed by FDA.
• Train on internal SOPs and requirements as applicable.
• Assist in providing regulatory strategy for assigned R&D projects.

Qualifications

• Required: Bachelor’s degree (or foreign equivalent) in Life Sciences, Chemistry, or a related field.
• Required: Minimum of 2 years of regulatory affairs experience, including:
• Solid oral dosage forms: tablets, hard gel capsules, softgel capsules, powders, granules, and pellets.
• Formulations: immediate-release, extended-release, delayed-release, complex generics (including peptides), and combination drug products.
• Regulatory submissions: P-INDs, INDs, NDAs, ANDAs.
• Responding to FDA deficiency comments and preparing submission responses.
• Regulatory advising for product launch readiness and post-approval changes.
• Familiarity with USFDA and ICH regulatory guidance.
• Experience with systems: Harmony Trackwise, VEEVA Vault (eCTD), Planisware, MS Word, PowerPoint, Excel.

Skills

• Regulatory writing and compilation for FDA submissions
• Regulatory strategy development and execution
• Regulatory compliance and quality systems awareness

Education

• Bachelor’s degree (or foreign equivalent) in Life Sciences, Chemistry, or a related field