Director, Regulatory Affairs, Strategy

Found in: Talent US C2 - 2 weeks ago

West Chester, United States Teva Pharmaceuticals Full time

The opportunity

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

This position will support the development and lifecycle management of therapies for conditions in Teva’s immuno-oncology and neuroscience portfolio, and other therapeutic areas as assigned. The position requires regulatory knowledge of IND and NDA/BLA content and submission experience.

Working within Teva Innovative Medicines, this role will contribute to the global and/or regional registration strategies to obtain marketing approval in focus countries as well as expanding into new indications with approved products. This role may include managing direct reports.

Travel Requirements: 10% (domestic and/or international travel for FDA or project team meetings)

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

RELOCATION ASSISTANCE AND WORK VISA SPONSORSHIP IS AVAILABLE

How you’ll spend your day

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.

Your experience and qualifications

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

Enjoy a more rewarding choice

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, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance

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