Senior Regulatory Affairs Leader, Global Strategy

Bayside Solutions, Inc.; Palo Alto (CA); On-site; USD 170,000 - 190,000; Full time

Job summary

Bayside Solutions seeks a Sr. Manager of Regulatory Affairs to oversee the regional regulatory strategy in line with the global plan.

You will collaborate with the Global Regulatory Leader to drive PoC through post-approval activities, leading local teams and shaping regulatory documents for Health Authorities. The role requires strong communication, deep regulatory knowledge, and the ability to navigate a fast-paced environment with 10% travel.

Qualifications

• Advanced scientific degree (PhD/MD/PharmD) or master’s with at least 5 years of drug development experience.
• Experience in Oncology is a great plus.
• Global regulatory procedures and practices knowledge desirable.
• Strong written, spoken, and presentation communication.
• Travel expected (10%).

Responsibilities

• Lead US regulatory strategy aligned with the global registration plan.
• Provide regulatory support from PoC through post-approval for projects.
• May serve as Global Regulatory Leader (GRL) with full regulatory responsibility.
• Lead local project teams in developing strategies for documents/activities.
• Ensure quality and content of submissions to Health Authorities.

Skills

Regulatory leadership

Global regulatory strategy

Drug development

FDA interactions

Health Authority liaison

Regulatory submissions

Documentation strategy

Briefing book ownership

Cross-functional leadership

Attention to detail

Travel

Education

PhD/MD/PharmD or Master’s with 5+ years drug development

Job description

Bayside Solutions seeks a Sr. Manager of Regulatory Affairs to oversee the regional regulatory strategy in line with the global plan.

You will collaborate with the Global Regulatory Leader to drive PoC through post-approval activities, leading local teams and shaping regulatory documents for Health Authorities. The role requires strong communication, deep regulatory knowledge, and the ability to navigate a fast-paced environment with 10% travel.