Associate Director - Regulatory Policy

We advance science so that we all have more time with the people we love.

As the Associate Director - Regulatory and Policy Affairs, you will be a member of our Regulatory group working with partners with both internal and external stakeholders to proactively shape regulatory environments to enhance patient access to the Roche/Genentech portfolio. In this role, you serve as key contact on regulatory policy and as a representative at industry organizations,
coalitions, and other public forums related to regulatory policy and advocacy.

The Opportunity

• You will have a strong knowledge of drug and biologics development and regulatory policies with focus on FDA, leading efforts to to influence the regulatory landscape.

• You find opportunities and challenges within the regulatory environment, establish priorities, and collaborate with key subject matter experts and partners to understand policy positions and advocacy plans.

• You build credibility and trusting relationships with regulators and other external customers in collaboration within Regulatory, Affiliates and other influencers to make Roche a trusted partner to regulatory authorities in the US.

• You act as a point of contact on drug development health regulatory policy issues with the US FDA, and other regulatory bodies, industry organizations and other advocacy groups, regions and Affiliates.

• You work with Regulatory Policy Network Leads to empower advocacy efforts to influence regulatory authorities in the development and implementation of emerging regulatory policies.

• You leverage collaborations with other key partners within Roche Diagnostics (e.g.,Government Affairs, Health Policy and Access) and Roche Group (e.g., Pharma regulatory policy) to optimize the power of OneRoche to influence regulators, governments and others who impact access to our products.

Who You Are

• You have a B.S. in a scientific field, advanced degree preferred

• 7+ years of relevant experience in regulatory policy

• You have 3+ years experience working on pharmaceutical, medical device or digital health regulatory policy initiatives.

• You have strong knowledge of regulatory processes including a deep understanding of the FDA, their priorities, guidance, and their staff.

• Experience working with government agencies, Congress, patient groups, think-tanks and public officials

• You have a strong understanding of regulatory processes, laws and regulations, both the informal and formal aspects of how regulatory policy is shaped and developed.

• You have demonstrated the ability to collaborate effectively and influence the drug community both internally and externally.

• You hold exceptional communication and advocacy skills, both written and verbal. Ability to communicate at all levels of leadership, both internally and externally.

Preferred Qualifications

• Knowledge of device, diagnostics and digital health a plus

• Proven accomplishments in implementing complex policy projects.

• Collaborates effectively with a diverse group of customers

• High degree of judgment and insight.

• Demonstrated problem-solving and decision-making abilities.

• Seen as a key contributor and go-to person for leadership in specific policy area(s)

• Consistent leadership and impact on a number of diverse work products

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Washington DC is $135,300.00 - $251,300.00 USD Annual. 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, 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.