H-1B Visa Senior Director Regulatory Affairs Jobs

THE POSITION

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, compliance, regulatory, policy, and enforcement frameworks governing the promotion and communication of pharmaceutical products and disease information.

We are hiring a Senior Director in Commercial Regulatory Affairs (CORA), who is a lead senior strategic advisor and people leader 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.

The Senior Director operates as a coach to a larger team of full-time and temporary staffing in CORA, but also serves as the day-to-day point-of-contact for Compliance partnering, as well as a deputy thought partner reporting into the Head of the CORA team. 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 a standing member of the CORA Leadership Team (LT), this Senior Director also contributes to CORA strategy, resource planning, talent development, and functional priorities, as well as deputy strategy enabler for the Head of the CORA team.

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: 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, tests the supporting analysis, guides recommendations, and ensures 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.

Competencies Identified for Success:

• Strategic Agility: Displays agility and focuses on constant improvement of systems and processes to enhance efficiency and productivity within CORA and the ecosystem of business partners it serves within the US and globally.

• 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: Prioritizes work to ensure the team is consistently delivering the highest value contributions to the organization. Proactively evolves and innovates practices in CORA to meet changing legal and business needs, focusing on solutions that are good for the enterprise rather than particular stakeholders. Balances rigorous standards with supportive management that empowers individual ownership and appropriate escalation.

• Inspiring and Influencing: Ability to persuade and influence leadership decisions to take action. Able to negotiate with external partners (e.g. vendors, customers, etc.).

• Managing Change: Knowledge of key organizational drivers and industry knowledge to maximize department performance. Able to execute and deliver results in fast changing business/compliance/regulatory requirements.

• 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: 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.

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 $213,400 to $396,200. 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.

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