Senior Director, Global Regulatory Strategy Lead – FDA Regulatory SME

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $206.5k - $393k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Responsible for oversight of complex product development within and across Therapeutic Areas • Provides FDA-specific subject matter expertise at the intersection of FDA regulations, guidances, policy, and product development strategy • Develops and implements global regulatory strategies to secure and maintain market approval • Ensures strategic messaging in US regulatory dossiers • Reviews regulatory documentation for compounds through all phases of development, including post-approval • Provides consultation and direction on compliance with US regulatory requirements • Recommends acceleration strategies • Provides training and advice to RA colleagues on FDA regulatory policy interpretation • Leverages deep FDA regulatory expertise to assess programs across therapeutic areas • Responsible for oversight of complex product development and project management • Communicates to the regulatory team and cross-functionally to carry out objectives established by executive management

🎯 Requirements

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification • minimum 15 years Regulatory, R&D, or equivalent industry-related experience • 10+ years of experience at the FDA with increasing responsibilities • Leadership experience working in a complex and matrixed environment • Experience bringing pharmaceutical products through development review and approval • Broad experience contributing to enterprise management of a portfolio of products • Experience developing and implementing successful global regulatory strategies • Experience interfacing with FDA and other government regulatory agencies • Strong verbal and written communicator with strong negotiation skills and strategic thinking • Strong business acumen and the ability to work under pressure • Extensive experience interfacing with multiple regional government regulatory agencies preferred. • Clinical foundation preferred with strong business acumen • Experience in multiple MOAs

🏖️ Benefits

• paid time off (vacation, holidays, sick) • medical/dental/vision insurance • 401(k) to eligible employees • participate in our long-term incentive programs