1+ months

Regulatory Affairs Associate II

Parsippany, NJ 07054
Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.  We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com


Position Summary: The Associate II, with minimal guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include ANDAs, amendments, supplements, annual reports and additional documents (for sterile products) as needed. Compiles and reviews ANDAs, amendments, supplements, annual reports, control documents, etc., for FDA submissions. Interacts effectively with functional business units in order to coordinate facilitate documentation required for submissions, ensuring that departmental timelines are met.


Essential Duties & Responsibilities

  • Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
  • Interacts with FDA and all Teva sites via written and phone communications.
  • Preparing Right First Time ANDAs and amendments for FDA submission.
  • Evaluating change controls and provide the regulatory assessment.
  • Performing special projects assigned by Regulatory Affairs management.
  • Other duties, as assigned, or as business needs require.
  • Timely submissions and expeditious approvals.
  • Maintains compliance with regulatory requirements for generic drugs for the US market.
  • Coaches and mentors other associates. Trains less senior associates to review change requests and provides guidance to other associates in the preparation of other FDA submissions.


Posted: 2020-05-22 Expires: 2020-08-07

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Regulatory Affairs Associate II

Teva Pharmaceuticals
Parsippany, NJ 07054

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast