The PositionLocations: South San Francisco, CA or Basel, Switzerland A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than four decades, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. Our team deeply values integrity and passion. We're committed to being a supportive work environment and to fostering mentorship and career development for our team members. If you share our values, are proactive, thoughtful, enjoy relationship-building, and are dedicated to excellence, we're excited to hear from you! The Head of Technical Regulatory Device & Combination will be responsible for the technical regulatory oversight of the entire Roche/Genentech device and combination product portfolio, covering all large and small molecules throughout the product life cycle. Additional responsibilities include developing and enhancing our expertise in combination product regulations, providing expert opinion at internal governance and proactively collaborating with internal partners on project strategies and initiatives, and proactively engaging with Health Authorities and industry associations to advance regulatory strategies. The incumbent will also be responsible for leading, managing and developing a group collocated in the US and Switzerland, and interacting with global partners. This position requires deep technical regulatory expertise with an emphasis in devices and combination products ,with demonstrated leadership experience, strategic agility, collaboration, and influencing skills.MAJOR RESPONSIBILITIES• Responsible for the regulatory strategies and regulatory risk management on all device and combination product projects for Roche/Genentech. Provides Technical Regulatory expertise and guidance to project teams, internal governance, and through Pharma Technical and Drug Development initiatives. • Responsible for external engagement with Health Authorities and Industry Associations on topics related to device and combination products. Represents the Roche/Genentech portfolio externally, maintains effective and timely internal knowledge management on the regulatory landscape and updates the company regulatory strategies accordingly. • As member of the leadership team, work collaboratively and strategically to establish priorities and directions for the organization. Contributes to the development of department business initiatives and facilitates their implementation. • Leads and guides a group of direct reports in Basel and South San Francisco, to provide excellent leadership, focusing on developing regulatory strategies that contribute to optimal project team strategies. Promote an end-to-end thinking in strategies and risk management. • Fosters a culture of high performance, trust and collaboration. Creates and cultivates a deep network and strengthens partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.• Interacts closely with key partners and stakeholders from technical, clinical and commercial functions within Roche/Genentech. Creates active and effective partnership, resolving issues and resource conflicts.• Manages resource allocation, and ensures that all projects within the area of responsibility are adequately supported.• Recruits, retains and develops team members. Establishes and implements training and development plans.• Support the creation, use and maintenance of systems, tools, and processes to enable technical regulatory leaders to lead and guide their project effectively. Proactively identify system gaps & elaborate plans to resolve those collaboratively.• Facilitate communication of project status reports, governance committee member briefings, and project hurdles to leaders.
Who You AreQUALIFICATIONS• Advanced degree in regulatory science, pharmaceutics, engineering or related field• 15 years+ experience in technical regulatory, drug development, with an emphasis on devices and combination products and inclusive of people management experience.• Extensive global regulatory knowledge on devices, including laws, regulations and directives, processes and issues in drug-device development. Includes expert-level knowledge of 21 CFR Parts 4, 820, 812, 803 & 312, ISO 13485 & 14971, Medical Device Directive (MDD 93/42/EEC) and other IEC/ICH guidelines. Demonstrated experience as a regulatory contributor for global regulatory device or drug submissions (IND, CTA, MAA, NDA, BLA, 510(k), CE-mark, PMA, etc.)• Highly collaborative with demonstrated ability to cultivate a network and manage stakeholder and senior leadership relationships.• Demonstrated experience of cross-functional leadership, including leading teams through different stages of product development and life-cycle management, advising others on strategic context and interconnectivities within the organization.• Broad technical expertise and interest in continuous learning in the areas of device and combination products, large and small molecule drug development.• Excellent verbal and written communication skills with success in influencing others in cross-functional settings. Excellent negotiation skills.• Proven ability to work proactively and think strategically• Expected business location: Basel (Switzerland) or South San Francisco (USA)• Expected travel 30%EOE STATEMENTGenentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our em...ployees are our most important asset & are dedicated to remaining a great place to work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page, www.gene.com