Associate Program Director, Commercial Regulatory Affairs (CORA)

Roche • South San Francisco, CA

12d • $120,200 - $223,200 • Onsite

About The Position

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

This role leads CMLRs and collaborates with cross-functional teams, commercial leadership, and advertising agencies. It provides regulatory guidance for assigned products, business areas, and projects; supports the development and approval of disease-state and promotional materials; and contributes to product labeling and regulatory strategy. The role also monitors CMLRs and provides management oversight in situations such as FDA communications, audits, and compliance violations. It is based at Roche’s Genentech campus in South San Francisco, California. Relocation benefits are not available.

Requirements

• Bachelor’s degree in life sciences, law, public policy, marketing, business, education, or a related discipline; a related field is preferred.
• At least 5 years of work experience in regulatory, legal, compliance, policy, auditing, training, communications, or a related discipline in the bio/pharma industry.
• Demonstrated working knowledge of the bio/pharma industry, including compliance, legal, clinical affairs, regulatory, and product marketing.
• Working knowledge of the legal and regulatory environment as it relates to healthcare compliance in the bio/pharma industry, including anti-kickback statutes, government fraud and abuse, off-label promotion, and the PhRMA Code.
• Demonstrates decision-making ability, including gathering information, reasoning through problems, expressing regulatory positions and rationale, and escalating issues in a timely and productive manner.
• Demonstrates technical and business expertise, applies emerging knowledge and trends, builds customer relationships, contributes expertise, and understands different functional perspectives.
• Demonstrates teamwork and collaboration, including resolving conflict, building collaborative relationships, supporting colleagues, and facilitating and leading cross-functional discussions.
• Demonstrates influencing and negotiation skills, including the ability to lead diverse teams and influence stakeholders at varying organizational levels without direct authority.
• Has strong verbal and written business communication skills and can prepare well-researched, appropriately toned responses to policy questions with limited management oversight.
• Has strong time-management and organizational skills and consistently meets deadlines without compromising work quality.
• Demonstrates strong attention to detail, process orientation, and the ability to identify appropriate resources.

Nice To Haves

• Graduate-level degree strongly preferred, such as a JD, MBA, MS, PharmD, other PhD, or a related degree.
• Previous experience in regulatory and/or commercial regulatory disciplines preferred.

Responsibilities

• Lead CMLRs and collaborate effectively with cross-functional groups and advertising agencies.
• Provide regulatory support and sound guidance for 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 matters, healthcare compliance, and ethics.
• Monitor CMLRs and provide management oversight in scenarios such as 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, guidelines, and Roche policies to facilitate development and approval of disease-state and promotional materials.
• Provide regulatory input on commercial concepts and draft materials.
• Support correspondence with the FDA, interpret FDA comments, and support follow-on correspondence such as resubmissions.
• Represent commercial regulatory affairs in Core Data Sheet (CDS) and U.S. product label development, as appropriate.
• Provide commercial regulatory affairs input into cross-functional regulatory strategy for assigned products or portfolios, as appropriate.
• 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.
• Participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products, as appropriate.
• Participate in special projects as assigned.

Benefits

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

What This Job Offers

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