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Summit Therapeutics, Inc.
Summit Therapeutics, Inc.
201 – 500 कर्मचारी
परामर्शविपणनस्वास्थ्य सेवा
Summit Therapeutics, Inc. एक बायोफार्मास्यूटिकल ऑन्कोलॉजी कंपनी है, जो गंभीर और अभी तक पूरी तरह से पूरी न हुई चिकित्सा आवश्यकताओं के लिए दवाएँ विकसित और व्यावसायीकृत करती है। इसका प्रमुख कार्यक्रम, इवोनेसिमैब (SMT112), PD-1 और VEGF को लक्षित करने वाली एक द्विविशिष्ट एंटीबॉडी है, जिसका Akeso से प्राप्त लाइसेंस के तहत गैर-लघु कोशिका फेफड़े के कैंसर और अन्य ठोस ट्यूमर के लिए तीसरे चरण के नैदानिक परीक्षणों में मूल्यांकन किया जा रहा है। कंपनी का कार्य अपने लाइसेंस प्राप्त क्षेत्रों में नैदानिक विकास, नियामक रणनीति और संभावित व्यावसायीकरण तक फैला हुआ है, जिसमें मरीजों और उनकी देखभाल करने वालों की सहायता के लिए बनाए गए उपचारों पर ध्यान केंद्रित किया जाता है।
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कंपनी की नौकरियाँ

Director of Regulatory Affairs, CMC

Lead global regulatory CMC filings for oncology medicines at Summit Therapeutics. Shape submission strategies and guide Health Authority engagement across clinical and commercial programs.

USसंयुक्त राज्य
$1,90,000 – $2,37,000 / वर्ष
रिमोटपूर्णकालिकलीडआवश्यक भाषा: अंग्रेज़ीअनुपालन

विवरण

  • Shape CMC regulatory strategy for clinical and commercial development and product lifecycle management
  • Oversee global Regulatory CMC submissions, including IND, IMPD, BLA, MAA, and post-approval supplements
  • Represent Regulatory CMC on project teams and provide strategic guidance
  • Coordinate with CMC, Supply Chain, Quality, and Regulatory Affairs teams to carry out regulatory strategies
  • Prepare and join Health Authority meeting requests, briefing books, and responses to information requests
  • Assess CMC submission sections for compliance and strategic consistency
  • Lead and contribute to discussions with Health Authorities
  • Set regulatory CMC strategies and assess risks for assigned projects
  • Drive ongoing process improvements with relevant teams and stakeholders
  • Explain global CMC rules and guidance to Summit personnel
  • Assist with Health Authority inspections
  • Raise regulatory compliance concerns with CMC Regulatory Affairs management
  • Keep up to date with global CMC regulations and guidance

आवश्यकताएँ

  • Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry, or a related science field
  • At least 10 years of Regulatory CMC and/or related pharmaceutical industry experience
  • Experience with biologics
  • Extensive knowledge of FDA, EU, and global regulations
  • Substantial experience setting regulatory strategy for complex products
  • Experience preparing CMC sections for complex regulatory submissions
  • Strong understanding of IND, CTA, BLA, and MAA processes
  • Experience working with Health Authorities on regulatory CMC matters
  • Mandarin proficiency in speaking and writing is highly desirable
  • Microsoft Office, electronic document management system, and document review tool proficiency is desirable
  • Strong computer and database skills
  • Careful, accurate, and discreet handling of information
  • Clear, concise verbal and written communication
  • Strong organizational skills
  • Critical thinking, problem-solving, and ability to work independently
  • Ability to manage multiple tasks and time-sensitive, highly confidential documents
  • Ability to explain complex ideas clearly
  • Ability to prioritize competing demands
  • Ability to work in a fast-paced, demanding, collaborative environment

लाभ

  • Total compensation may include a bonus, stock, benefits, and/or other applicable variable compensation
  • Equal opportunity employer committed to nondiscrimination in recruitment, hiring, training, and promotion

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