1+ months

Director, Regulatory Policy & Intelligence

Washington, DC 20004

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. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

 

Impact of Teva: Around 200 million people worldwide take one of our medicines every day. In the United States, where Teva is the leading generic pharmaceutical company, one out of every nine prescriptions is filled by a Teva product. In the UK it is one out of every six and in Canada it is one out of every six. In addition, many prescription medications made by other companies include active pharmaceutical ingredients produced by Teva.

 

The Director, Regulatory Policy & Intelligence, will be a key member of the Global Regulatory Policy team, facilitating regulatory policy development within Teva and working to shape and influence FDA policy in line with Tevas goals.  In this role, he or she will drive toward Tevas policy goals by encouraging global policy collaboration on key initiatives, drafting important written advocacy with regulatory agencies, liaising with trade associations, and ensuring consistent internal and external communication on regulatory policy issues. 

 

 

Essential Duties & Responsibilities:

 

  • Support global regulatory policy and intelligence function:
  • Coordinate matters of regulatory policy and intelligence to support Tevas business goals in individual markets and on a global level
  • Create and oversee targeted policy groups and task forces on key policy issues and establish the communication tools and practices necessary to maximize Tevas influence on regulatory policy matters, worldwide 
  • Proactively monitor for regulatory intelligence developments, analyze issues and identify affected stakeholders, distribute relevant information, and coordinate the development of appropriate responses
  • Represent Teva at US-based trade associations (e.g., PhRMA, AAM, etc.) 
  • Manage public comment processes by drafting public comments and other documents and ensuring that Tevas position is accurately reflected in the comments of Tevas trade associations
  • Work closely in partnership within R&D, Commercial, GA, Legal, Operations, and Communications stakeholders to develop and implement plans to maximize Tevas reputation and influence with health authorities, trade associations and industry partners 
  • Develop and maintain relationships with health authorities, external-facing organizations, trade associations, and pharmaceutical industry counterparts
  • Support and provide regulatory insight into broader policy efforts underway by GA, Communications, and other groups
  • Drive the generation of Teva regulatory policy priorities and create opportunities for policy advocacy and engagement on special areas of focus, including by leveraging agency contacts and trade associations
  • Work closely with R&D colleagues to support renegotiation of the Prescription Drug, Generic Drug, and Biosimilar User Fee Agreements and implementing legislation
  • Serve as a subject matter expert based on in-depth knowledge of key regulatory and scientific issues and analyses of policy initiatives and proposals
  • You may reside in New Jersey, Washington DC or West Chester, PA

 

Competencies:

  • Demonstrated understanding of the varied roles and responsibilities of a complex, global regulatory environment
  • Strong working knowledge of the regulations and guidances governing drugs and biologics in all phases of development, with an advanced understanding of US framework particularly in the context of generic drugs and biosimilars; understanding of global health regulatory frameworks preferred     
  • Strong foundation of verbal and written communication skills and capacity to draft strong written arguments; strong Powerpoint skills required
  • Demonstrated excellence in (i) understanding complex scenarios in order to identify and evaluate relevant issues and risks; (ii) proposing solutions that take into consideration the relevant business objectives; and (iii) communicating those issues, risks, and solutions clearly and concisely
  • Sound judgment, commitment to ethical conduct, and a high level of professionalism       
  • Strong interpersonal skills and an ability to work collaboratively, with a solution-oriented approach, in cross-functional teams within R&D, Legal, GA, Commercial, and other functional areas
  • Strong organizational skills and an ability to handle multiple responsibilities simultaneously and still meet quality and timeliness standards under pressure

 

Categories

Posted: 2020-12-16 Expires: 2021-01-21

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Director, Regulatory Policy & Intelligence

Teva Pharmaceuticals
Washington, DC 20004

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