Director, Commercial Regulatory Affairs (CORA)

Job description

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 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. 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. Competencies Identified for Success: Strategic Agility: Articulates and drives long-term objectives; balances immediate business needs with long-term improvements. Anticipates how changes in law, regulation, enforcement, and policy may affect commercial strategy and provides clarity and focus on the priorities that matter most. Judgment & Risk Assessment: Exercises sound, independent judgment in complex, ambiguous, or precedent-setting matters. Integrates regulatory, legal, policy, enforcement, and commercial context; distinguishes among available pathways; and provides clear, well-reasoned recommendations that enable accountable business decisions. Coaching and Developing Talent: Actively coaches and mentors direct reports to strengthen their strategic advisory capabilities, regulatory judgment, and business acumen. Identifies development needs, provides constructive feedback, and creates opportunities for team members to grow and succeed. Performance Management & Accountability: Sets clear expectations and holds the team accountable for the quality, consistency, timeliness, and practical value of its advice and risk assessments. Balances rigorous standards with supportive management that empowers individual ownership and appropriate escalation. Inspiring and Influencing: Influences across organizational levels without direct authority; builds trust within the team and across the business. Communicates complex regulatory and risk considerations clearly and credibly and shapes decisions through expertise, judgment, and a practical understanding of business objectives. Managing Change: Leads teams through change effectively, providing the context, direction, and support necessary to maintain focus and performance. Remains adaptable and helps the team translate new legal, regulatory, policy, enforcement, or business developments into effective ways of working. Teamwork and Collaboration: Pulls diverse teams together to achieve common goals; navigates complex, cross-functional organizational environments while fostering an inclusive, collaborative culture. Builds effective partnerships across Legal, Commercial, Medical, Regulatory, and other relevant functions. WHO YOU ARE 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: 10+ 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. Leadership Experience: 2–3+ years of people management experience preferred. 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. Location This role is located at Roche’s Genentech campus in South San Francisco, California. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of California is $181,160 to $336,440. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .