Commercial Regulatory Affairs (CORA) is part of the Global Product and Access Legal (GPAL) organization within the Global Legal Pharma Department. CORA serves as a strategic advisory function to U.S. and global commercial leaders on the legal, regulatory, policy, and enforcement frameworks governing the promotion and communication of pharmaceutical products and disease information.
We are hiring Directors in Commercial Regulatory Affairs (CORA) , who are senior strategic advisors and people leaders responsible for helping leaders in commercial and medical affairs navigate complex regulatory and business risk in developing and executing strategies for communicating about Roche disease areas and products to customers and patients. They provide advice, counsel, and risk assessments informed by FDA laws, regulations, and guidance; relevant requirements of other health authorities; the external enforcement environment; and evolving policy developments.
Directors operate as player-coaches. They directly advise the business on complex, novel, and high-impact matters while leading, developing, and coaching CORA regulatory professionals who perform similar advisory and risk-assessment work. They oversee the quality, consistency, and escalation of their teams’ assessments and recommendations. As standing members of the CORA Leadership Team (LT), Directors also contribute to CORA strategy, resource planning, talent development, and functional priorities.
THE OPPORTUNITY
Key Responsibilities:
Strategic Advice, Counsel & Risk Assessment: Serve as a senior strategic advisor to U.S. and global commercial leaders on complex advertising, promotion, disease-awareness, and product-communication matters. Interpret and apply FDA laws, regulations, guidance, enforcement precedent, and relevant health-authority requirements to proposed commercial strategies. Provide practical, business-oriented advice and risk assessments that identify regulatory considerations, evaluate potential pathways and consequences, and enable informed decision-making.
Player-Coach Leadership: Maintain direct responsibility for a portfolio of complex or high-impact matters while leading and managing regulatory affairs professionals who advise the business and assess regulatory risk. Review significant or escalated assessments, test the supporting analysis, guide recommendations, and ensure that the team’s advice is clear, consistent, and appropriately calibrated across products and therapeutic areas.
CORA Leadership: Lead and manage assigned CMLR(s) and their activities, providing strategic leadership in advertising and promotion for Roche products. Serve as a standing member of the CORA Leadership Team, contributing to the development of the CORA vision, strategy, business, talent, and resource plans.
Cross-Functional Decision Leadership: Chair assigned cross-functional commercial review and decision-making committees and serves as the senior CORA and GPAL regulatory representative in those forums. Lead the discussion and resolution of complex advertising and promotional issues, communicate integrated regulatory and legal risk assessments, and advise cross-functional leaders on potential pathways and implications for business strategy. Identify matters requiring escalation or specialized legal advice and coordinate with GPAL attorneys and other subject-matter experts. Coordinate with GPAL legal for consults with outside counsel as needed.
External Environment, Enforcement & Policy Analysis: Monitor and interpret developments affecting pharmaceutical advertising and promotion, including FDA warning and untitled letters, enforcement activity, relevant litigation and case law, agency guidance and rulemaking, policy developments, industry trends, and evolving health-authority positions. Assess the potential implications for Roche and translate those developments into forward-looking strategic advice for Legal and business leaders.
Strategic & Operational Leadership: Design and…