Director, Regulatory Strategy & Business Development

ABBVIE; North Chicago (IL); On-site; USD 182,000 - 346,000; Full time

Job summary

AbbVie seeks a Director of Regulatory Business Development to lead regulatory assessments, due diligence, and strategy for external opportunities, including in-licensing, out-licensing, and acquisitions. You will coordinate cross-functional teams, manage risks, and negotiate regulatory aspects of deals.

You will interact with R&D, manufacturing, and commercial partners to align regulatory plans with business objectives and global requirements.

Qualifications

• Bachelor's degree in life sciences required.
• 7+ years regulatory experience.
• Drug development experience in US & Canada region.
• Strong leadership and project management in a matrix environment.
• Experience interfacing with major government regulatory bodies.
• 10+ years regulatory experience preferred; lead regulatory product strategist in multiple regions.

Responsibilities

• Prepare regulatory scientific assessments for in-license/out-license and acquisitions.
• Lead regulatory evaluations and recommendations for venture investments.
• Support out-license/divestiture of AbbVie development stage products.
• Develop regulatory strategy and inputs into development plans and product concepts.
• Negotiate regulatory activities within contracts and deal models.
• Communicate regulatory risks and recommendations to management and stakeholders.
• Understand global regulatory environments and trends across major regions.
• Manage internal regulatory resources and budget.

Skills

Regulatory leadership

Project management

Cross-functional collaboration

Global regulatory strategy

Negotiation

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie seeks a Director of Regulatory Business Development to lead regulatory assessments, due diligence, and strategy for external opportunities, including in-licensing, out-licensing, and acquisitions. You will coordinate cross-functional teams, manage risks, and negotiate regulatory aspects of deals.

You will interact with R&D, manufacturing, and commercial partners to align regulatory plans with business objectives and global requirements.