Associate Director, Global Regulatory Strategy - International

Olema

San Francisco, United States
Base: $176,000 - $188,000 annually; bonus/equity: ...
On-site
Global regulatory strategies
Clinical trial submissions
Health authority interactions
Contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development

Job Summary

  • Contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development.
  • Represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions and support global health authority interactions.
  • Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs.

Matching Summary

Contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development.

Salary

Base: $176,000 - $188,000 annually; Bonus/Equity: equity, bonus; Benefits: benefits

Skills & Requirements

Must-have

  • Global regulatory strategies
  • Clinical trial submissions
  • Health authority interactions
  • Regulatory landscape monitoring
  • Cross-functional team collaboration

Nice-to-have

  • Fast-paced environment
  • Scientific discipline background
  • Oncology therapeutic area experience

Key Requirements

  • Minimum 10 years of experience with Bachelor's degree
  • Minimum 7 years of experience with Master's degree
  • Minimum 5 years of experience with PhD
  • Direct experience preparing INDs/CTAs
  • Knowledge of FDA, EMA, ICH guidelines

Work Rights

Not specified

Tailored Resume

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