Teva Pharmaceutical Industries-posted 3 months ago
Full-time • Entry Level
Weston, FL
5,001-10,000 employees
Chemical Manufacturing

Actavis Laboratories FL, Inc. seeks a Regulatory Affairs Associate III responsible for reviewing change controls for approved Abbreviated New Drug Applications (ANDAs), unapproved but submitted ANDAs, and making appropriate regulatory determinations. The role involves writing, reviewing, and compiling documentation and data necessary for submission of assigned PINDs, INDs, ANDAs, and NDAs with limited supervision from the manager. Additionally, the associate will write, review, and compile documentation necessary for responses to FDA Deficiency letters, as well as for Correspondences and post-approval supplements. The position requires reviewing applicable revised and new regulations and guidance distributed by the FDA, training on internal SOPs, and assisting in providing regulatory strategy for assigned R&D projects.

  • Review change controls for approved ANDAs and unapproved but submitted ANDAs.
  • Write, review, and compile documentation for submission of assigned PINDs, INDs, ANDAs, and NDAs.
  • 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 FDA.
  • Train on internal SOPs and requirements as applicable.
  • Assist in providing regulatory strategy for assigned R&D projects.
  • Bachelor's degree (or foreign equivalent) in Life Sciences, Chemistry, or a related field.
  • Minimum of 2 years of regulatory affairs experience.
  • Experience with solid oral dosage forms: tablets, hard gel capsules, softgel capsules, powders, granules, and pellets.
  • Experience with formulations: immediate-release, extended-release, delayed-release, complex generics (including peptides), and combination drug products.
  • Experience with regulatory submissions: P-INDs, INDs, NDAs, ANDAs.
  • Experience responding to FDA deficiency comments and preparing submission responses.
  • Experience with 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.
  • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment.
  • 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
  • Paid Time Off including vacation, sick/safe time, caretaker time, and holidays.
  • Company paid Life and Disability insurance.
  • Employee Assistance Program.
  • Employee Stock Purchase Plan.
  • Tuition Assistance.
  • Flexible Spending Accounts.
  • Health Savings Account.
  • Life Style Spending Account.
  • Volunteer Time Off.
  • Paid Parental Leave, if eligible.
  • Family Building Benefits.
  • Virtual Physical Therapy.
  • Accident, Critical Illness and Hospital Indemnity Insurances.
  • Identity Theft Protection.
  • Legal Plan.
  • Voluntary Life Insurance and Long Term Disability.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service