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Teva Pharmaceuticals Regulatory Affairs Associate II in Parsippany, New Jersey

Regulatory Affairs Associate II

Date: May 22, 2020

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

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

Job Description

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.

Qualifications

  • BS in a scientific discipline or equivalent education and related experience

  • Minimum four years pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory, or production experience preferred.

  • Basic computer skills such as Word, Excel and familiarity with the internet

  • Ability to manage timelines with a project team environment

  • Ability to work independently and on teams

  • Good verbal and written communication skills

  • Mustbe well organized, detail oriented, have the ability to multi-task and manage changing priorities

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

EOE including disability/veteran

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