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Regulatory Affairs Specialist II - Miramar FL

Date: May 9, 2019

Location: Miramar, Florida, US, 33025

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.

Job Description

The Regulatory Affairs Specialist is responsible for establishing, maintaining, and providing administrative management of the Regulatory Documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs).

 

Essential Functions

Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP's), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times

 

Generates, facilitates and maintains all study related regulatory documents from pre­ study through study close out, ensuring quality, accuracy, and timeliness

Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements

 

Prepares and maintains records for archiving and/or retrieval

 

Reviews all regulatory documents prior to Sponsor/Monitor/ Regulatory Authority visits.

 

Works with Clinical Study Managers, clinical staff, IRB, and study Sponsors to resolve site and study related Regulatory concerns issues

 

Provides administrative and operational support to internal departments and clinical management teams

Qualifications

Education A Bachelor's Degree in a health field is required.

Experience

Experience organizing documents, Trial Master File preferred, in a health environment

Minimum of three (3) years of experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity and/or experience in a medically related profession, pharmaceutical, medical device company, or as a clinical research coordinator at an investigative site

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

 

Certification/Licensure CCRC preferred

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Manager Regulatory Affairs

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.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami

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