Senior Manager, Regulatory Affairs

Summit Therapeutics Inc.

Oxford, United Kingdom
Base: €80,000 – €95,000 eur; bonus/equity: not spe...
On-site
3+ years regulatory affairs experience
7+ years pharmaceutical industry experience
Knowledge of ema and european regulations
Summit Therapeutics Inc. is seeking a Senior Manager of Regulatory Affairs to support regulatory activities related to clinical trials in oncology. The ideal candidate will have extensive experience in regulatory affairs, particularly within the European market, and will be responsible for managing submissions and collaborating with cross-functional teams

Job Summary

  • Summit Therapeutics is a biopharmaceutical oncology company dedicated to improving quality of life through global Phase 3 clinical studies.
  • The Senior Manager will provide ownership of projects including clinical trial applications and marketing authorization pre-submission activities in Europe.
  • The role requires collaborating with cross-functional teams to plan regulatory documents and manage interactions with health authorities.

Matching Summary

Match Score: 85

Summit Therapeutics Inc. is seeking a Senior Manager of Regulatory Affairs to support regulatory activities related to clinical trials in oncology. The ideal candidate will have extensive experience in regulatory affairs, particularly within the European market, and will be responsible for managing submissions and collaborating with cross-functional teams.

Salary

Base: €80,000 – €95,000 EUR; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 3+ years Regulatory Affairs experience
  • 7+ years pharmaceutical industry experience
  • Knowledge of EMA and European regulations
  • Experience with CTAs and MAA submissions
  • Strong written and oral communication skills

Nice-to-have

  • Experience interacting with CROs for trial activations
  • Familiarity with EU health authority systems like IRIS and CTIS
  • Proficiency in electronic document management systems
  • Experience leading internal kick-off meetings
  • Background in oncology clinical studies

Key Requirements

  • BA/BS degree in biological or health sciences required
  • Master's, PhD, or PharmD preferred
  • Minimum 3+ years Regulatory Affairs experience
  • Minimum 7+ years pharmaceutical/biotech experience
  • Not specified

Work Rights

Not specified

Tailored Resume

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