Global Regulatory Strategy Director - Oncology Solid Tumors

BioSpace; Brisbane (CA); On-site; USD 232,000 - 331,000; Full time

Job summary

BioSpace in Brisbane, CA seeks a senior Regulatory professional to lead global regulatory strategy and high-quality submissions. You will collaborate with SVP Regulatory Affairs and cross-functional teams to drive regulatory filings and lifecycle management in alignment with company SOPs.

The role requires extensive regulatory affairs experience, strong communication, and the ability to manage multiple projects and interactions with health authorities.

Qualifications

• Bachelor's degree in life-sciences or related field; advanced degree preferred.
• Minimum 12 years in regulatory affairs strategy with oncology experience.
• Strong knowledge of FDA, EMA and ICH guidelines and regulations.
• Experience planning clinical trial and regulatory filings with health authorities.
• Proven ability to manage multiple projects and timelines.

Responsibilities

• Develop and execute global regulatory strategy across regions.
• Lead preparation of high-quality submissions (IND, CTAs, NDAs, MAAs).
• Collaborate with Health Authorities and cross-functional teams.
• Monitor submission plans, timelines and regulatory risk.
• Define requirements for regulatory systems and tools.
• Manage consultants and contractors as needed.

Skills

Regulatory strategy

FDA knowledge

Cross-functional leadership

Project management

Regulatory submissions

Communication skills

Education

Bachelor's degree in life-sciences

Tools

Veeva RIM

Smartsheet

Excel

Job description

BioSpace in Brisbane, CA seeks a senior Regulatory professional to lead global regulatory strategy and high-quality submissions. You will collaborate with SVP Regulatory Affairs and cross-functional teams to drive regulatory filings and lifecycle management in alignment with company SOPs.

The role requires extensive regulatory affairs experience, strong communication, and the ability to manage multiple projects and interactions with health authorities.