Teva Regulatory Affairs Associate III 

United Kingdom, England 

732995072

Actavis Laboratories FL, Inc. seeks a Regulatory Affairs Associate III responsible for the following:

· 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.

REQUIREMENTS:Bachelor’s degree (or foreign equivalent) in Life Sciences, Chemistry, or a related field.
Plus a 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.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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