Associate Program Director, Commercial Regulatory Affairs (CORA)

Location: hirify.global campus in South San Francisco, California, United States. Relocation benefits are not available.

Salary: $120,200–$223,200 annually, with a discretionary annual bonus potentially available.

Company

hirify.global, a member of the Roche group, develops medicines through biotechnology and scientific research for serious and life-threatening diseases.

What you will do

• Lead Commercial Medical Legal Regulatory Review Committees and collaborate with cross-functional groups and advertising agencies.
• Provide regulatory guidance for assigned products, business areas, portfolios, and projects.
• Facilitate the development and approval of disease-state and promotional materials in line with FDA regulations and Roche policies.
• Support FDA correspondence, comment interpretation, resubmissions, audits, and compliance-violation processes.
• Represent commercial regulatory affairs in Core Data Sheet and U.S. product-label development.
• Monitor regulatory activities, communicate status to stakeholders, and participate in regulatory strategy and special projects.

Requirements

• Bachelor’s degree in life sciences, law, public policy, marketing, business, education, or a related discipline preferred.
• Graduate-level degree strongly preferred, such as JD, MBA, MS, PharmD, PhD, or a related qualification.
• At least 5 years of experience in regulatory, legal, compliance, policy, auditing, training, communications, or related disciplines within the bio/pharma industry.
• Knowledge of the bio/pharma industry and healthcare compliance, including anti-kickback statutes, government fraud and abuse, off-label promotion, and the PhRMA Code.
• Strong decision-making, influencing, negotiation, communication, organizational, and attention-to-detail skills.
• Must work at the hirify.global campus in South San Francisco; relocation benefits are not available.

Culture & Benefits

• Work within a scientific organization focused on developing medicines for serious and life-threatening diseases.
• Benefits are available according to the company’s benefits program.
• A discretionary annual bonus may be available based on individual and company performance.
• Equal opportunity employment and applicant accommodation support are provided.