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ProfileGroup Director, Commercial Regulatory Affairs Duties: Are part of senior management in CORA and are standing members of the CORA Leadership Team. Have responsibility for multiple PRCs across the assigned therapeutic area(s) or for full cross-portfolio CORA compliance and functional excellence (FE). Demonstrate mastery of the review committee process and regulatory technical knowledge. Oversee and direct larger teams and large-scale departmental programs and projects that have impact across Genentech and/or more broadly across Roche . Play a lead role in the overall CORA vision, strategy, business and resource plans; including overseeing and guiding team implementation. Are accountable for the design and effective execution of team strategy, plans, objectives, tactics, budgets and other resource utilization and optimization. Manage team budget and infrastructure. Regularly lead CORA-wide infrastructure or other CORA cross-portfolio or cross-discipline strategic projects or programs. Lead cross-functional review/decision committees of significant impact across Genentech or more broadly Roche. Routinely interact with executives across Genentech and/or Roche to influence business decisions at the highest organizational levels. Represent CORA externally to industry bodies, associations and/or regulatory authorities, including as needed in official FDA communications and sign-off of 2253s. Are relied upon for expert regulatory guidance and apply a strategic approach to problem-solving. Effectively integrate regulatory, legal and commercial context and business knowledge to address significantly complex problems. Keep current in the areas of regulatory, healthcare compliance and ethics. Proactively identify and address compliance issues. Typically operate with a planning horizon of 3 or more years. Lead a team of direct and indirect reports; manage managers and individual contributors. Make critical contributions to the overall infrastructure and long-term capacity and resource planning across CORA. Assume accountability for developing future CORA leaders. Play a key role in CORA annual and long-range talent management and succession planning. Identify, recommend, implement and maintain the required infrastructure for department/team. Lead recruitment, hiring and on-boarding for direct report positions. Develop, implement and maintain a robust succession plan for key positions in his/her area of responsibility. Oversee direct reports’ work to ensure on-time, on-target and within-budget results, including ensuring staff members meet or exceed goals and expectations. Ensure direct reports are appropriately trained, developed and coached. Responsible for performance management of direct reports. Lead routine and ad hoc meetings and other communications across assigned area. Ensure effective hiring, development, performance management and retention of indirect reports. Coach and mentor CORA management and staff across varying levels. CORA Leadership:. Supervise work of direct reports and be involved in all matters related to FDA communications, audits, POC presentations and compliance violations. Monitor select PRCs of direct reports quarterly (at a minimum) to assess delivery of regulatory position, meeting facilitation, and negotiation skills. Seek opportunities to increase consistency in decision-making across PRCs. Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for Genentech products. Drive internal and external awareness and ever-increasing knowledge and expertise across his/her staff regarding laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Play a lead role in the annual and longer-term development of CORA’s vision, strategy, goals, objectives and infrastructure. Maintain consistent oversight of deliverables across your team. Establish and manage new and existing relationships with relevant offices and personnel in the Food and Drug Administration (FDA) and serve, as needed, as a primary liaison to such external parties. With your team, maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters and policy issues. Ensure your team communicates significant changes or other relevant matters to internal partners and stakeholders in a timely, targeted and thorough manner. As assigned, oversee and guide timely development and approval of disease state and promotional materials across the assigned therapeutic area(s). As applicable, provide regulatory leadership and guidance on strategies for advertising, promotional, educational and other relevant commercial tactics, including overseeing and guiding multiple PRCs across the assigned therapeutic area(s). Lead development and implementation of effective strategies for FDA marketing, advertising and communications submissions, CORA compliance and/or CORA functional excellence (FE). As applicable, oversee and guide development, implementation and maintenance of CORA compliance and FE priorities, goals, programs, initiatives, tools, resources and other activities. Drive effective and efficient support across your team in the development of cross-functional regulatory strategies; ensuring provision of commercial regulatory affairs expertise, insights, perspective and recommendations. Play a lead role in development and implementation of new or updated PDR and/or CORA-specific Standard/Department Operating Procedures (SOPs/DOPs). Represent CORA internally and externally, including industry conferences, workshops, meetings, or other relevant external forums. Identify, conceive, assign and oversee other special projects, as and when assigned, or otherwise requested.
Qualification and Experience
Qualifications: Bachelor's Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred). Graduate-level Degree strongly preferred (JD Degree, MBA, MS, PharmD or other PhD, or related discipline). 10+ years’ work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry. Specific work experience in regulatory affairs, including advertising/promotional activities compliance, strongly preferred. 4+ years’ people management experience, including experience managing other people managers. 4+ years’ experience leading large-scale cross-functional project teams or other forums in design, development, and implementation of policies or programs with significant organizational impact. Experience interacting with outside regulators or other authorities preferred. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.). Has impeccable ethics. Demonstrates, or has proven abilities to demonstrate, Roche Values, Competencies and Leadership Commitments. Regarded as a subject matter expert in regulatory. Has outstanding cross-functional team leadership skills and has consistently excelled as a cross-functional team leader: has proven abilities to effectively lead and manage larger teams of management and staff across multiple disciplines. Consistently provides expertise and support in guiding cross-functional projects/teams to mitigate risks and capitalize on opportunities. Can build vision and strategy and lead others in the accomplishment of such. Outstanding influencing and negotiation skills: demonstrates consistently effective influence to achieve important results/outcomes. Strong verbal and written business communication and presentation skills: highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications across varying organizational levels. Strong conflict resolution skills. Prepares well-researched and properly-toned emails in response to policy questions. Thinks “outside the box” for solutions. Applies creative problem-solving and appropriate business solutions to effectively address compliance risk. Outstanding time management and organizational skills: proven abilities to manage multi-team , multidisciplinary, often complex and competing, objectives, goals and priorities to effective and efficient conclusion. Demonstrates ability to identify appropriate resources. Exercises good judgment in terms of when to leverage internal resources. Outstanding business acumen: has in-depth understanding of the industry, the company and its inner-workings and has consistently made significant contributions to the business. Strong process orientation: has proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness. Strategic Agility – Articulates wise, long-term objectives and strategies. Balances what will pay off in the short run with what will provide long-term improvements. Provides clarity and focus on a few key priorities. Infuses the organization with a sense of purpose. Addresses and resolves conflict by creating an atmosphere of openness and trust. Understands and motivates other people to perform at their best. Finds opportunities to build community, celebrate and have fun. Is inspirational; helps people to see the importance of what they are doing. Is skilled at managing and influencing staff, peers and senior management. Is good at promoting an idea or vision; persuading. Works effectively with other people over whom he or she has no direct authority. Effectively manages change: explaining the context, answering questions, and patiently listening to concerns. Effectively involves key people in the design and implementation of change. Introduces needed change even in the face of opposition. Helps direct reports resolve their conflicts constructively. Is able to pull people together to achieve a common goal. Builds diverse teams and leverages them to deliver exceptional results. Finds and attracts highly talented and productive people.
Job ID: 3235330511