Regulatory Affairs Manager

4 days ago


Parsippany, New Jersey, United States Teva Pharmaceutical Industries Full time
Job Description

Teva Pharmaceuticals USA is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with FDA regulations and guidelines for our generic medicines.

Key Responsibilities:

  • Lead the development, revision, and submission of labeling documents for NDA 505(b)(2) applications and ANDAs.
  • Collaborate with cross-functional teams to ensure alignment with product strategy and regulatory requirements.
  • Provide guidance and leadership to direct reports on labeling best practices and regulatory compliance.
  • Ensure timely submission of labeling documents to the FDA and maintain accurate records.
  • Stay up-to-date with FDA regulations, guidelines, and SOPs applicable to US labeling.

Requirements:

  • MSc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience.
  • 6-7 years of US labeling experience, with a focus on NDA 505(b)(2) applications and 1 year of supervisory experience.
  • Pharmaceutical industry experience required, specifically in Regulatory Affairs and US NDA 505(b)(2)/ANDA.
  • Excellent communication and organizational skills, with the ability to work independently and as part of a team.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

How to Apply:

If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application through our internal career site. We look forward to hearing from you



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