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Regulatory Affairs Associate

Date: Oct 10, 2021

Location: Weston, Florida, US, 33331

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!
 
R&D:
Teva’s Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies
 

Job Description

 

 

  • Carries out responsibilities in accordance with the organization’s policies, procedures,
  • and state, federal and local laws.
  • Prepares timely original ANDAs, amendments, and supplements, including interfacing
  • with other departments to obtain the necessary components and drafts reports and
  • narrative components in accordance with regulatory agencies’ guidelines for approval by
  • Manager.
  • Prepares other regulatory documents such as annual reports for approval by Manager.
  • Prepares, assembles, complies and publishes regulatory submissions in electronic
  • (eCTD) as required.
  • Reviews non-technical change controls and assigns appropriate regulatory determination
  • for submission.
  • Reviews, analyzes and generates technical documents from other departments or
  • companies, e.g., summary of manufacturing processes, clarifications and explanations of
  • Company procedures.
  • Evaluates and researches any submission deficiencies, additional information or testing
  • as requested by regulatory authorities.
  • Participates in problem solving activities for assigned projects.
  • Reviews and suggests updates departmental SOP’s.
  • Performs special projects assigned by Regulatory Affairs management.
  • Complies with good housekeeping and safety practices.
  • Ensures project deadlines and performance standards are established and met.
  • Ensures compliance with all Company policies and procedures, including safety rules and regulations.

Qualifications

 

 

  • Minimum Bachelor’s Degree in Life Sciences or related field from an accredited college or university.
  • Minimum 3 years related pharmaceutical regulatory affairs experience, or minimum 3 years equivalent pharmaceutical industry experience, or minimum 2 years of satisfactory performance as a Regulatory Affairs Associate.
  • Ensuring compliance with all company policies and procedures, including safety rules
  • and regulations.

 

Physical Requirements and Working Conditions

  • Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor and moderate noise levels.
  • Work is performed in an office environment.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

 

Sr Manager Regulatory Affairs

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.


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