Regulatory Associate - III

Job Title

Responsibilities:

Review change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and make appropriate regulatory determination.

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's distributed by FDA.

Train on internal SOPs (Standard Operating Procedure) and requirements as applicable.

Assist in providing regulatory strategy for assigned R&D projects.

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.

Requirements:

Bachelor's degree (or foreign equivalent) in Life Sciences, Chemistry, or a related field Plus a minimum of 4 years of regulatory affairs experience.

Solid oral dosage forms: tablets, hard gel capsules, softgel capsules, powders, granules, and pellets.

Familiarity with USFDA and ICH regulatory guidance.

Experience with systems: Harmony Trackwise, VEEVA Vault (eCTD), Planisware, MS Word, PowerPoint, Excel.