Director, Commercial Regulatory Affairs (CORA)
Core
Senior strategic advisor and people leader providing legal, regulatory, policy, and enforcement framework advice to U.S. and global commercial leaders on pharmaceutical product promotion and disease information communication.
Role type
Director, Commercial Regulatory Affairs (CORA)
Builds
Strategic advisory services and risk assessments for Roche disease areas and products
Domain
Pharmaceutical industry, Regulatory Affairs, Legal Compliance
Required skills
Strategic advice and risk assessment, FDA law and regulation interpretation, Player-coach leadership, Cross-functional decision leadership, External environment and policy analysis, Strategic and operational leadership, People leadership, Compliance and functional excellence
Preferred skills
Graduate-level degrees (JD, MBA, MS, PharmD, PhD), 10+ years of work experience in regulatory, legal, compliance, policy, or audit
Technologies
None stated
Responsibilities
Serve as a senior strategic advisor to U.S. and global commercial leaders on complex advertising, promotion, disease-awareness, and product-communication matters; Lead and manage assigned CMLR(s) and their activities; Chair assigned cross-functional commercial review and decision-making committees; Monitor and interpret developments affecting pharmaceutical advertising and promotion; Design and lead the implementation of team strategy, objectives, tactics, and resource requirements; Represent CORA externally to industry bodies, associations, and regulatory authorities; Lead, develop, and coach a team of direct and indirect reports; Proactively identify and address compliance risks and oversee the development and implementation of CORA compliance priorities
Seniority
Director, strategic advisor and people leader