Regulatory Associate III

Regulatory Associate III

Apply for the role at Katalyst CRO.

• 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.

• 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.

Associate

Contract

Legal

Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Katalyst CRO by 2x.