Specialty/Senior Specialty Representative - Bone Health - Missoula/Billings, MT (Overlay)

Director-level position overseeing US promotional regulatory strategy for immunology brands at AstraZeneca. This role ensures FDA compliance across all promotional materials and channels while enabling commercial execution through cross-functional collaboration with medical, legal, and commercial teams.

Responsibilities

• Drive regulatory review and risk assessment for promotional materials across healthcare professional, consumer, and managed markets segments
• Lead regulatory strategy development, risk identification, and contingency planning to protect brand integrity while enabling compliant messaging
• Serve as primary FDA liaison for assigned brands; manage advisory requests, enforcement actions, and competitor complaints
• Develop and deliver regulatory training to build compliance capability across commercial and medical stakeholders
• Monitor FDA regulatory trends and guidance documents; share implications with cross-functional teams for proactive planning

Requirements

• Bachelor's degree in science
• 3+ years promotional regulatory affairs or FDA OPDP/APLB experience
• 5+ years total pharmaceutical, biotech, or FDA industry experience
• Strong knowledge of FDA promotional regulations and labeling processes
• Advanced degree in life sciences, pharmacy, or law preferred
• 10+ years US promotional regulatory affairs with OPDP/APLB interactions preferred
• People leadership experience with track record of building high-performing teams