Associate Program Director, Commercial Regulatory Affairs (CORA)
Core
Lead Commercial Regulatory Affairs (CORA) committees and provide regulatory support for assigned products, cross-portfolio activities, and promotional material development within the global Pharma Division.
Role type
Senior individual contributor (Associate Program Director)
Builds
Promotional materials, Core Data Sheets, product labels, and regulatory strategies for assigned products
Domain
Bio/pharma industry, commercial regulatory affairs, healthcare compliance
Deliverable
product features
Required skills
Regulatory guidance, FDA communications, compliance risk management, cross-functional collaboration, marketing strategy influence, material development oversight, audit monitoring, policy interpretation
Preferred skills
Commercial regulatory experience, bio/pharma industry knowledge, legal/regulatory environment expertise
Technologies
None stated
Responsibilities
Lead CMLRs and collaborate with cross-functional groups and agencies; Provide regulatory support and guidance for assigned products; Manage departmental projects and address compliance issues; Monitor CMLRs for FDA communications, audits, and violations; Collaborate with commercial leadership to influence marketing strategies; Facilitate development and approval of promotional materials; Support FDA correspondence and interpretation of comments; Represent commercial regulatory for CDS and label development; Provide input into cross-functional regulatory strategies
Seniority
Senior, hands-on IC
