Katalyst CRO
Regulatory Associate III
Katalyst CRO is hiring a Regulatory Associate III based in Phoenix, AZ.
Responsibilities
Review change controls for approved and unapproved Abbreviated New Drug Applications (ANDAs) and make appropriate regulatory determinations.
Write, review, and compile documentation and data required for the submission of assigned P-INDs, INDs, ANDAs, and NDAs with limited supervision.
Write, review, and compile documentation for responses to FDA Deficiency letters.
Write, review, and compile documentation for Correspondences and post‑approval supplements.
Review applicable revised and new regulations and guidance distributed by the FDA.
Train on internal SOPs and regulatory requirements as applicable.
Assist in providing regulatory strategy for assigned R&D projects.
Prepare documentation for formulations including immediate‑release, extended‑release, delayed‑release, complex generics (including peptides), and combination drug products.
Prepare submission responses to FDA deficiency comments.
Provide 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.
Experience with solid oral dosage forms: tablets, hard gel capsules, softgel capsules, powders, granules, and pellets.
Familiarity with US FDA and ICH regulatory guidance.
Proficiency in systems such as Harmony Trackwise, VEEVA Vault (eCTD), Planisware, MS Word, PowerPoint, and Excel.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Legal
Location: Phoenix, AZ
Salary: $130,400.00 – $215,200.00
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Responsibilities
Review change controls for approved and unapproved Abbreviated New Drug Applications (ANDAs) and make appropriate regulatory determinations.
Write, review, and compile documentation and data required for the submission of assigned P-INDs, INDs, ANDAs, and NDAs with limited supervision.
Write, review, and compile documentation for responses to FDA Deficiency letters.
Write, review, and compile documentation for Correspondences and post‑approval supplements.
Review applicable revised and new regulations and guidance distributed by the FDA.
Train on internal SOPs and regulatory requirements as applicable.
Assist in providing regulatory strategy for assigned R&D projects.
Prepare documentation for formulations including immediate‑release, extended‑release, delayed‑release, complex generics (including peptides), and combination drug products.
Prepare submission responses to FDA deficiency comments.
Provide 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.
Experience with solid oral dosage forms: tablets, hard gel capsules, softgel capsules, powders, granules, and pellets.
Familiarity with US FDA and ICH regulatory guidance.
Proficiency in systems such as Harmony Trackwise, VEEVA Vault (eCTD), Planisware, MS Word, PowerPoint, and Excel.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Legal
Location: Phoenix, AZ
Salary: $130,400.00 – $215,200.00
#J-18808-Ljbffr