Associate Program Director, Commercial Regulatory Affairs (CORA)

Genentech • Daly City, CA

1d • $120,200 - $223,200 • Onsite

About The Position

Commercial Regulatory Affairs (CORA) is part of Roche’s Global Product and Access Legal organization, which interprets the needs of worldwide health authorities and provides regulatory intelligence for the global Pharma Division. CORA reports to the Head of Global Product and Access Legal in the Global Legal Pharma Department. Associate Program Directors of Commercial Medical Legal Regulatory Review Committees (CMLRs) provide regulatory support for assigned products and cross-portfolio activities. They may lead cross-functional CMLRs with oversight from CORA Program Directors and managers, and are experienced individual contributors expected to work with increased independence.

The role leads CMLRs, supports assigned products, business areas, and projects, and provides regulatory guidance. It collaborates with commercial leadership, cross-functional partners, and advertising agencies to facilitate timely development and approval of disease-state and promotional materials. The position applies FDA regulations and guidelines and Roche policies, contributes to commercial concepts and draft materials, supports FDA correspondence and interpretation of FDA comments, and represents commercial regulatory affairs in Core Data Sheet and U.S. product-label development. The role also monitors CMLRs and provides management oversight in situations such as FDA communications, audits, and compliance violations; keeps stakeholders informed about activities and status; and participates in special projects and, as appropriate, regulatory strategy and Regulatory Affairs Functional Team activities.

The position is based at Roche’s Genentech campus in South San Francisco, California. Relocation benefits are not available. The expected salary range for the California primary location is $120,200 to $223,200. Actual pay depends 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. The position qualifies for the benefits detailed at the linked benefits information. Genentech is an equal opportunity employer and prohibits unlawful discrimination. Applicants needing an accommodation for the online application process may contact the company using its accommodations form.

Requirements

• Bachelor’s degree; life sciences, law, public policy, marketing, business, education, or a related discipline is preferred.
• At least 5 years of work experience in regulatory, legal, compliance, policy, auditing, training, communications, or related disciplines in the biopharma industry.
• Working knowledge of the biopharma industry, including compliance, legal, clinical affairs, regulatory affairs, and product marketing.
• Working knowledge of the legal and regulatory environment relevant to healthcare compliance in the biopharma industry, including anti-kickback statutes, government fraud and abuse, off-label promotion, and the PhRMA Code.
• Demonstrated decision-making skills, including gathering relevant information, thinking through problems clearly and logically, communicating regulatory positions and rationale, and escalating issues in a timely and productive manner.
• Ability to apply expertise and emerging knowledge and trends, build customer relationships, contribute expertise across teams, earn trust, and understand different organizational perspectives.
• Ability to collaborate, resolve conflict, build strong working relationships, support colleagues, and facilitate and lead cross-functional discussions.
• Influencing and negotiation skills, including ability to lead diverse teams and influence stakeholders at varying organizational levels without direct authority.
• Strong verbal and written business communication skills, including effective, professional communication and the ability to prepare well-researched, appropriately toned responses to policy questions with limited management oversight.
• Good time-management and organizational skills, consistently meeting deadlines without compromising work quality.
• Strong attention to detail and consistent quality of work.
• Process-oriented approach, including the ability to plan required steps and sequencing to ensure quality outputs.
• Ability to identify appropriate resources.

Nice To Haves

• Graduate-level degree strongly preferred, such as a JD, MBA, MS, PharmD, other PhD, or related discipline.
• Previous experience in regulatory and/or commercial regulatory disciplines preferred.
• Bachelor’s degree in life sciences, law, public policy, marketing, business, education, or a related discipline preferred.

Responsibilities

• Lead Commercial Medical Legal Regulatory Review Committees (CMLRs) and collaborate with cross-functional groups and advertising agencies.
• Provide regulatory support and sound regulatory guidance to assigned products, business areas, and projects.
• Manage departmental projects and deliverables, proactively identifying and addressing compliance issues.
• Integrate regulatory risk and context with business knowledge, while staying current in regulatory, healthcare compliance, and ethics matters.
• Monitor CMLRs and provide management oversight for FDA communications, audits, and compliance violations.
• Collaborate with commercial leadership to influence marketing strategies and facilitate timely development and approval of promotional materials.
• Interpret and apply FDA regulations and guidelines and Roche policies to facilitate timely development and approval of disease-state and promotional materials.
• Provide regulatory input on commercial concepts and draft materials.
• Support FDA correspondence, interpret FDA comments, and assist with follow-on correspondence such as resubmissions.
• Represent commercial regulatory affairs in Core Data Sheet and U.S. product-label development.
• As appropriate, provide commercial regulatory affairs input into cross-functional regulatory strategy for assigned products or portfolios.
• Keep internal partners and stakeholders informed about primary CMLR/CORA activities and status.
• Consult the direct manager on matters related to FDA communications, audits, and compliance violations.
• As appropriate, participate as an ad hoc member of the Regulatory Affairs Functional Team for relevant products.
• Participate in special projects as assigned.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for benefits detailed at the linked benefits information; specific benefits are not listed in the posting.
• Relocation benefits are not available for this position.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior