Senior Regulatory Professional

3 weeks ago


Menlo Park, California, United States Summit Therapeutics Sub, Inc. Full time

The estimated salary for this role is $182,500 per year, based on the job requirements and industry standards. This compensation package includes benefits, bonus, stock options, and other applicable variable compensation.

Job Description
  • Main Responsibilities:
    • Provide regulatory guidance to project teams and key sub-teams at study level
    • Assess, develop, and implement competitive global regulatory strategies for ivonescimab
    • Own regulatory activities at molecule and study-level, including clinical trial application (CTA) and IND submissions
    • Broadly apply regulatory/technical knowledge of government regulations and skills
  • Key Skills:
    • Strong written, oral communications in English
    • Experience interfacing with government regulatory agencies and health authorities
    • Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
  • Requirements:
    • BA/BS degree in the biological or health-related sciences required, graduate-level degree a plus
    • Relevant (bio)pharmaceutical industry experience, including a minimum of 5+ years of experience in regulatory affairs

The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits compensation.



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