Vice President, Head of Global Regulatory Strategy

The Position

The Opportunity

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Pharma Technical Regulatory (PTR) is a global regulatory network providing the strategy, expertise, and guidance to ensure world-class technical regulatory support for clinical trial applications, new molecular entity market applications, and post-approval change submissions.

The Global Regulatory Strategy Head leads a global organization overseeing the CMC regulatory strategy for our programs encompassing all modalities and from early development through to end of lifecycle.

The incumbent leads a focused global team of regulatory leaders, TRLs, and submissions leads responsible for both the development and deployment of CMC regulatory strategy, including governance and portfolio management, as well as the execution of core regulatory work.

The Global Regulatory Strategy Head is accountable for CMC regulatory strategies to guarantee that all global products manufactured at or on behalf of Roche or supplied to Roche (DS, DP, and packaging operations) fulfill and maintain our right to operate by meeting regulatory expectations.

Key Roles and Responsibilities

Provide regulatory leadership and oversight to approximately 90 regulatory professionals at all stages in their careers located across multiple locations and oversee CMC regulatory activities in support of Roche's Development and Marketed Products portfolio.

Serve, at all times, to improve Roche’s standing with Health Authorities.

• Effectively lead the organization, which includes operating in compliance with the regulatory requirements, efficiently resourcing programs / projects, ensuring timely completion of projects, adhering to budget targets, and proactively developing and implementing continuous improvement solutions.
• Act as PTR Chair or single decision maker around filings within PT Governance bodies (e.g., LSTDC Meetings, PNC Meetings, Filing Go - as delegated by PTR Head).

Including chairing of Regulatory Committees accountable for the E2E strategy for either Biologics and / or Synthetic Molecules.

Foster employee development. Coach, mentor, and develop regulatory professionals by stretching team members, including taking challenging assignments.

Expected to embody the Roche operating principles.

• Foster a culture of high performance, trust, and collaboration. Build and cultivate a strong network and strengthen partnerships to facilitate knowledge exchange and the sharing of best practices and lessons learned.
• As a member of the Pharma Technical Regulatory leadership team, work collaboratively and strategically to establish priorities and direction for the organization to meet its business needs, being innovative and efficient to achieve the company’s long-range goals.

Contribute to the development of department business initiatives and facilitate their implementation.

Establish oneself as an internal expert and thought leader for internal stakeholders on cross-functional CMC strategy. Accountable to ensure aligned priorities, strategic direction, and effective working relationships with both internal stakeholders and Health Authorities.

Ensure staff members provide internal teams with timely and appropriate strategic and executional direction on regulatory authority interactions.

Contribute to regulatory intelligence gathering and to the development of internal and cross-functional regulatory policy.

Who You Are

• At a minimum MS in science disciplines plus relevant experience; Post Graduate Degree (Master or PhD) is a plus.
• 17+ years of experience in the core activities of Technical Operations, Quality and / or Regulatory, with demonstrated experience with core regulatory CMC processes.
• 10+ years of leadership experience, experience in leading leaders and leading global teams.
• Extensive experience in CMC and / or Regulatory with proven success leading global organizations and cross-functional teams (cross-location).
• Excellent track record in people management, including performance management and people development. Demonstrated ability to connect with and inspire staff at all levels.
• Strong track record of developing organizations, including effective talent management, capability building, as well as driving regulatory innovation and operational effectiveness.
• Strong knowledge of the regulatory environment including interactions with Health Authorities.
• Experienced global leader with strong business acumen and a successful track record role modeling and passionately advocating VACC (Visionary, Architect, Coach, and Catalyst) leadership.
• Proven track record of working with and influencing multi-disciplinary teams and external experts.
• Ability to maintain a global strategic mindset and to inspire high performance.
• Effective global communicator with the ability to mobilize teams to our purpose and vision.
• Possesses strategic agility and proficiency in risk-management principles. Drive for continuous improvements and operate with a lean mindset.

The expected salary range for this position based on the primary location of California Base Pay Range $330,650 - $408,450 Annual.

Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long-term incentive program.

This position also qualifies for the benefits detailed at the link provided below.

Benefits

Location : This position is based in the Bay area, CA

Relocation : Relocation assistance is being offered

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status.

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