Remote Senior VP, Regulatory, Quality & Medical Writing

Dennis Partners; United States; Remote; USD 375,000 - 425,000; Full time

Benefits offered by this job

Annual target bonus

Equity

Comprehensive benefits

Job summary

A leading biopharmaceutical company in the United States is seeking a Senior Vice President to oversee their Regulatory, Quality, and Medical Writing functions. In this remote role, you will lead the development of global regulatory strategies for oncology programs and manage several high-functioning teams. Your responsibilities will include ensuring compliance with regulatory guidelines and leading key interactions with health authorities, including the FDA. This position offers a competitive salary range of $375,000 to $425,000 plus bonuses and equity.

Qualifications

• 15+ years in Regulatory Affairs in pharma/biotech organizations.
• Strong Regulatory experience in oncology across all phases.
• Regulatory Affairs Certification (RAC) preferred.

Responsibilities

• Oversee Regulatory, Quality, and Medical Writing functions.
• Develop global regulatory strategies for oncology programs.
• Manage regulatory filings including INDs and NDAs.
• Lead interactions with FDA and other Health Authorities.
• Forecast and manage budgets for Regulatory functions.

Skills

Regulatory leadership

Influencing stakeholders

Team development

Communication skills

Education

Bachelor degree in a scientific discipline

Advanced degree (MS, PharmD or PhD)

Job description

A leading biopharmaceutical company in the United States is seeking a Senior Vice President to oversee their Regulatory, Quality, and Medical Writing functions. In this remote role, you will lead the development of global regulatory strategies for oncology programs and manage several high-functioning teams. Your responsibilities will include ensuring compliance with regulatory guidelines and leading key interactions with health authorities, including the FDA. This position offers a competitive salary range of $375,000 to $425,000 plus bonuses and equity.