Regulatory Strategy & Business Development Director

AbbVie Inc.; North Chicago (IL); Vor Ort; USD 200.000 - 350.000; Vollzeit

Benefits dieser Stelle

Medical/dental/vision insurance

401(k) plan

Paid time off

Zusammenfassung

AbbVie Inc. seeks a Director of Regulatory Business Development to lead regulatory scientific assessments, due diligence, and development strategy for external business opportunities.

This role interfaces with Business Development, R&D, Manufacturing, and Commercial teams globally to identify regulatory risks and mitigations for acquisitions and collaborations. The position requires extensive regulatory experience in US/Canada with leadership in complex, matrix environments, and strong

Qualifikationen

• Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
• 7+ years regulatory experience; US & Canada drug development knowledge; 5+ years in a strategic leadership role.
• Experience interfacing with major government regulatory agencies.
• 10+ years regulatory activities with lead regulatory product strategist in two major regions in addition to the US (preferred).

Aufgaben

• Prepare oral and written regulatory scientific assessments for in-license/out-license and development opportunities.
• Prepare GRS evaluations and recommendations for venture investments in platform technologies.
• Lead GRS activities supporting out-license/divestiture of AbbVie development stage compounds or marketed products.
• Develop regulatory strategy and inputs into future development plans and product profiles.
• Negotiate regulatory activities and requirements aligned with development scenarios and deal structures.
• Communicate decisions and recommendations to internal management and external partners.

Kenntnisse

Strategic leadership

Regulatory strategy

Project management

Cross-functional collaboration

Communication

Negotiation

Ausbildung

Bachelor's degree in life sciences

Advanced degree preferred

Jobbeschreibung

AbbVie Inc. seeks a Director of Regulatory Business Development to lead regulatory scientific assessments, due diligence, and development strategy for external business opportunities.

This role interfaces with Business Development, R&D, Manufacturing, and Commercial teams globally to identify regulatory risks and mitigations for acquisitions and collaborations. The position requires extensive regulatory experience in US/Canada with leadership in complex, matrix environments, and strong