Teva Director Regulatory Affairs Strategy - Innovative Medicine West Chester PA 

United States, Pennsylvania, East Bradford Township 

503403375

The Director, Global Regulatory Affairs, is a strategic role that will be responsible for developing, coordinating, and implementing regulatory strategies forearly and/or late stage development programsfor innovative biologic and small molecule products, as well as marketed products.

On-Site in West Chester, PA or Remote (anywhere in the US)

• Responsible for ensuring timely development of regulatory strategies through a global regulatory team approach for branded products.
• As a global or regional lead within a global regulatory team, develops/coordinates/implements regulatory strategy as a valued member of a multi-disciplinary project team for branded products
• Leads the team in planning, preparation, and execution of meetings with health authorities (e.g., FDA, EMA). Point-lead for interfacing with health authorities.
• Regularly reports to management on progress against objectives and plans.
• Plans and directs projects and provides technical background, inspiration, leadership, regulatory intelligence, and consultation to cross-functional colleagues as well as members of the global regulatory team.
• Lead facilitator for the submission and approval of regulatory applications and coordinates appropriate responses to health authorities to resolve outstanding regulatory issues.
• Provides training and mentorship to regulatory staff.

Required:

• Bachelor’s Degree in scientific field or equivalent combination of education and related work experience
• Minimum of 8 years of relevant pharmaceutical industry experience, including at least 5 years in a strategic position in regulatory affairs with proven experience (filing and defense of major submissions such as IND/NDA/BLA/CTA/MAA).

Preferred:

• PhD or Masters in relevant discipline, or professional degree (eg, DVM, DDS, MD, PharmD)
• Prior oncology experience preferred.
• Experience in Oncology, Immuno-oncology, and Neuroscience
• Working knowledge of relevant drug and biologic regulations and guidances / guidelines applicable to registration and approval of drugs or biologics
• Working knowledge of relevant drug, biologic and combination product laws regulations/guidances and how they inform regulatory strategy for innovative medicine development; working in a matrixed cross functional project team and global regulatory team

Senior Director, Regulatory Affairs

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