VP, Global RA Policy and Intelligence
Washington, United States, District of Columbia, 11111
Who we are
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 centred around our core therapeutic areas which include neuroscience, immunology, and immuno-oncology. We are continually developing patient-centric solutions and significantly growing both our generic, biosimilar, and innovative 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!
The opportunity
The VP, Global Regulatory Policy & Intelligence role reports to Teva’s SVP, Global Regulatory Affairs (GRA) and serves as a key member of the Global Regulatory Affairs Leadership Team. In addition, this role serves on the GRA Strategy Board focusing on providing guidance and insight to GRA leaders managing key drug projects in Innovative Medicines, Generics and Biosimilars. This role leads and manages the Global Regulatory Policy and Intelligence function partnering with GRA leaders in North America, Europe and the International Regions. This position serves as a key point of contact for Teva with our health authority interfaces across the globe – especially the FDA and EMA. Insights from the leader in this role specific to how Regulatory Policy decisions are made within health authorities – particularly FDA - will add value to Teva’s drug project submissions in all 3 business areas: Generics, Innovative Medicines and Biosimilars.
This position will be based in Washington, DC area.
Key responsibilities
Coordinate all matters of regulatory policy and intelligence to support Teva’s business goals, including industry initiatives and trade association representation (including PhRMA, AAM, EFPIA, IFPMA, Medicines for Europe, IGBA, etc.).
Develop and maintain an internal network of stakeholders and establish the communication tools and practices necessary to maximize Teva’s influence on regulatory policy matters, worldwide.
Develop and maintain relationships with health authorities, external-facing organizations, trade associations, and pharmaceutical industry counterparts.
Monitor and distribute regulatory information from global health authorities on a regular basis, distribute regulatory intelligence updates, and manage public comment processes.
Drive the generation of Teva regulatory policy priorities and create opportunities for policy advocacy and engagement on special areas of focus, including by leveraging trade association priorities.
Work closely in partnership within R&D and Commercial, GA, Legal, Operations, and Communications stakeholders to develop and implement plans to maximize Teva’s reputation and influence with health authorities, trade associations and industry partners.
Follows Teva Safety, Health, and Environmental policies and procedures.
Skills and qualifications
A BS Degree is required; BS degree in a science related field (Chemistry, Biology, etc.) is preferred.
15 + years of relevant pharmaceutical experience, including a preference for past experience working at the FDA.
A good understanding of Health Authority organization roles & responsibilities in North America, Europe and some International geographies (e.g. Japan, China).
Possess an understanding of the varied roles and responsibilities of a complex, global regulatory environment.
Possess a strong working knowledge of regulations and guidance that govern drugs and biologics in all phases of development, with an advanced understanding of industry associations in North America, Europe and Asia Pacific.
Strong organizational skills and an ability to handle multiple responsibilities simultaneously and still meet quality and timeliness standards under pressure.
Sound judgment, commitment to ethical conduct, a high level of professionalism and intellectual curiosity, with a commitment to continuous learning and improvement.
Provide training for Regulatory, R&D, and Commercial functions on legal and regulatory issues related to FDA, EMA, PMDA and China National Medical Products Administration.
Reports To
SVP, Global Regulatory Affairs
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