Teva Pharmaceuticals USA, Inc.

Regulatory Affairs Associate II- Pre Approval, Generics WESTON, FL

US-FL-Weston
Requisition #
17-19897
# Positions
1
Experience (Years)
3
Category
Regulatory Affairs - Regulatory Affairs

Overview

Our Generics Regulatory Affairs team in Weston, FL is currently seeking a Regulatory Affairs Associate II to join their team.  The Regulatory Associate II will be responsible for preparing regulatory submissions in accordance to FDA guidelines.

 

 

Responsibilities

 

The Regulatory Affairs 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 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.

 

  • 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.
  • 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 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.

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

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