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Assoc Dir Regulatory Affairs (Promotional Review and Labeling)

Date: Oct 8, 2021

Location: West Chester, Pennsylvania, US, 19380

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

 

 

The Sr. Manager/Associate Director, Regulatory Affairs, Promotional Review & Labeling will be primarily responsible for the regulatory review of advertising and promotional materials for assigned branded products within Teva’s specialty pharmaceuticals portfolio.  The portfolio includes products in the respiratory, CNS, oncology, pain, and women’s health therapeutic areas.

 

Responsibilities:

 

  • Review advertising, promotional and other related materials for assigned products to ensure compliance with applicable FDA laws, regulations, and guidance.
  • Provide regulatory expertise and guidance within a collaborative cross-functional team that includes Legal, Medical Affairs, and Marketing.
  • Serve as primary contact with FDA Office of Prescription Drug Promotion (OPDP) for assigned products.
  • Review and approve Form FDA-2253 submissions to OPDP.
  • Work cross-functionally to develop and implement revised/new labeling and supporting documentation for assigned products.
  • Maintain a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
  • Perform other duties as assigned.

Qualifications

 

 

  • Minimum of a BA/BS Degree, preferably in a health/life sciences or related field.
  • Minimum 3-5 years of experience in the review of advertising and promotional materials within the pharmaceutical industry.
  • Strong knowledge of FDA regulations and their interpretation relevant to prescription drug advertising, promotion, and labeling.
  • Working knowledge of the drug/biologic development process, including labeling development process.
  • Demonstrated ability to work independently and collaboratively in a fast-paced environment.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

 

Dir RA US Brand Management, RA Respiratory & Oncology

Already Working @TEVA?

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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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