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← Summit Therapeutics

Associate Director, Regulatory Affairs

Summit Therapeutics
Location
Remote (US)
Posted
12 days ago
Department
Regulatory Affairs
What they actually want (must-haves)
  • BA/BS degree in Biotechnology, Biological Sciences, or related field
  • Minimum of 5+ years of experience in regulatory affairs
  • Global regulatory experience
  • Knowledge of US FDA and international pharmaceutical guidance and regulations
  • Strong written and oral communication skills in English
  • Strong negotiation skills and ability to work under pressure
Nice to have
  • Graduate-level degree (e.g., MS, PhD, or PharmD)
  • Knowledge of Chinese
  • Experience interacting with CROs in managing ex-US CTAs
  • Experience with electronic document management systems
What the job really is

The Associate Director of Regulatory Affairs at Summit Therapeutics will oversee regulatory activities for clinical studies, particularly focusing on ivonescimab in oncology. Daily tasks include providing regulatory guidance, developing global regulatory strategies, managing submissions to regulatory agencies, and ensuring compliance with regulations. The role also involves liaising with health authorities and leading cross-functional teams in regulatory meetings.

Benefits
  • Pay range of $168,000 — $198,000 USD
  • Potential for bonus, stock, and other variable compensation
Things to weigh
  • Remote position may require self-motivation and discipline
  • Role involves significant responsibility and pressure due to regulatory deadlines
  • No specific mention of work-life balance or flexibility in hours
Job score3/5
Benefits1/5
Freshness5/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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