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Regulatory Affairs Associate III

Date: Jun 9, 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

 

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.
 
Position Summary: 
In your new position as an  Regulatory Affairs Associate III you will lead and manage applications through the regulatory approval process, including preparation of original ANDAs, NDAs, amendments and related correspondence to the FDA in order to obtain timely approvals.  You may represent the regulatory affairs department through interactive communication with various internal and external stake holders.  You will also be responsible for evaluating change controls to provide for accurate regulatory filing assessments in accordance to guidance documents.  In addition, he/she will accurately populate and maintain the databases and trackers in real time (change control tracker/Global Trackwise (GTW), Workload Tracker and Global Insight).
 

Essential Duties & Responsibilities:

  • Independently review and prepare regulatory submissions for drug products under development and review by FDA.  Interface with R&D on a regular basis to ensure project-specific regulatory strategy is met.  From “regulatory point for view” continually assess the product development process and reports and provide feedback to R&D on the ANDA projects assigned.
  • Initiate regulatory strategy on CMC issues throughout the drug development process. Serve as a regulatory knowledge base by continually working with R&D on ANDA projects and documenting the regulatory strategy on several milestones, such as, QTPP/CQA, composition, product and process design, various specification settings, manufacturing, stability design and stability data analysis.
  • Coordinate responses to the FDA with appropriate personnel and departments to resolve outstanding regulatory filing issues. Keep current with the FDA/ICH regulations pertaining to GDUFA, CMC and regulatory filing aspects by independent learning, attending conferences and symposiums.
  • Approve IIG ingredients and assures that they are in accordance with the FDA database.  Assesses and approves change controls.
  • Manage the preparation for FDA meetings and provides strategic guidance on the organization of these meetings
  • Provide regulatory training to the department on an as-needed basis.  Other projects and duties as required/assigned.

Qualifications

 

Education Required:

  • Bachelor of Science in a scientific discipline or Master’s degree

 

Experience Required:

  • 4 years in Pharmaceutical Industry and a minimum of 4 years in Regulatory Affairs.
  • (Previous Injectable/sterile product experience required for steriles position).

 
Experience Preferred:

  • Three plus years of experience working within Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical industry.
  • Specialized or Technical Knowledge Licenses, Certifications needed: RAC certification beneficial but not required; working

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.


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