Senior Director, Commercial Regulatory Affairs (CORA)

Required Education, Experience and Knowledge

• Education: Bachelor’s Degree (life sciences, law, public policy, marketing, business, education, or related discipline). Graduate-level degrees (JD, MBA, MS, PharmD, PhD, or related) strongly preferred.
• Experience: 15+ years of work experience in regulatory, legal, compliance, policy, auditing, training, communications, or related disciplines in the bio/pharma industry, including experience advising commercial stakeholders on complex or high-impact matters required.
• Leadership Experience: 5+ years of people management experience required. Demonstrated ability to lead, develop, and mentor professionals while maintaining direct responsibility for substantive advisory work.
• Regulatory Knowledge: In-depth knowledge of the bio/pharma industry and the laws, regulations, guidance, enforcement environment, and industry standards relevant to pharmaceutical advertising, promotion, and product communications. Demonstrated ability to translate that knowledge into practical advice and risk assessments for business leaders.
• Subject Matter Expertise: Regarded as a subject matter expert in commercial regulatory affairs, with specific experience in advertising and promotion strongly preferred. Demonstrated ability to integrate regulatory, legal, policy, enforcement, and commercial considerations in complex decision-making.
• Project Leadership: Demonstrated ability to lead policy, program, or project development from conception to implementation with significant organizational impact.

• 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: At least 50% of time is spent managing and leading across the practice area of direct reports, and the remainder maintaining direct responsibility for a portfolio of more complex and high-impact matters.  Provides oversight of the largest team of CORA full-time and temporary staff (approximately 6+ individual contributors).. Reviews 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. Serves as thought partner to the Head of the CORA team, helping to solve and drive business outcomes for multiple business areas with their breadth and depth of regulatory expertise.
• 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. Also serves as day-to-day point of contact for Compliance partnering on US and Global matters.
• 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 lead the implementation of team strategy, objectives, tactics, and resource requirements across the assigned therapeutic area or functional cluster. Establish expectations and standards for regulatory risk assessment, identify issues with broader portfolio or enterprise implications, and determine when matters require escalation to CORA or GPAL leadership.
• External Representation: Represent CORA externally to industry bodies, associations, and regulatory authorities, including managing FDA communications and official regulatory submissions as needed. Use external engagement and regulatory intelligence to inform internal strategy, risk assessment, and business decision-making.
• People Leadership: Lead, develop, and coach a team of direct and indirect reports. Oversee onboarding, performance management, development planning, and talent succession. Build a high-performing, inclusive team culture that combines individual accountability with appropriate review, guidance, feedback, and escalation. Regarded, and relied upon by others, as a leader within the greater Global Legal Pharma team.
• Compliance & Functional Excellence: Proactively identify and address compliance risks and oversee the development and implementation of CORA compliance priorities, SOPs/DOPs, and functional excellence initiatives. Use insights from monitoring, investigations, audits, and process performance to strengthen controls, improve decision-making, and enable sustainable business practices.