Director, Regulatory Affairs, CMC

🕒 October 21

🇺🇸 United States – Remote

💵 $190k - $237k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 1%

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Summit Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2003

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Summit Therapeutics, Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of innovative medicinal therapies aimed at improving quality of life for oncology patients. The company is particularly committed to addressing serious unmet medical needs through its lead investigational therapy, ivonescimab, a novel bispecific antibody designed to target both PD-1 and VEGF. Summit’s initiatives include ongoing Phase III clinical trials to evaluate ivonescimab's effectiveness in treating non-small cell lung cancer, highlighting their dedication to patient-centered care and technological advancement in the field of oncology.

📋 Description

• Develop and execute CMC regulatory strategies for clinical and commercial development and lifecycle management • Manage preparation of high-quality global Regulatory CMC submissions, including IND, IMPD, BLA, MAA, and post-approval supplements • Represent Regulatory CMC on project teams and provide strategic regulatory input • Collaborate with CMC, Supply Chain, Quality, and Regulatory Affairs teams to implement regulatory strategies • Plan and participate in Health Authority meeting requests, briefing books, and responses to information requests • Review CMC sections of regulatory submissions for compliance and strategic alignment • Lead and participate in regulatory interactions with Health Authorities • Develop Regulatory CMC strategies and risk assessments for assigned projects • Identify continuous process improvements and engage relevant teams and stakeholders • Interpret global CMC regulations and guidelines for Summit personnel • Support Health Authority inspections • Escalate regulatory compliance issues to CMC RA Management • Maintain current knowledge of global CMC regulations and guidance

🎯 Requirements

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required • 10 or more years Regulatory CMC experience and/or related Pharmaceutical industry experience required • Experience in biologics required • Thorough and extensive knowledge of FDA, EU and global regulations required • Significant experience developing regulatory strategy for complex products • Experience preparing CMC sections for complex regulatory submissions • Excellent understanding of IND, CTA, BLA and MAA processes • Experience engaging with health authorities on regulatory CMC topics • Proficiency in Mandarin Chinese (spoken and written) highly desirable • Proficiency with Microsoft Office Suite, electronic document management systems, and document review tools desirable • Strong computer and database skills • Attention to detail, accuracy and confidentiality • Clear and concise oral and written communication skills • Excellent organizational skills • Critical thinking, problem solving, and ability to work independently • Ability to multitask and manage time-sensitive, highly confidential documents • Ability to communicate complex ideas clearly • Ability to prioritize conflicting demands • Ability to work in a fast-paced, demanding, and collaborative environment

🏖️ Benefits

• Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation • Equal Opportunity Employer commitment and non-discrimination in recruitment, hiring, training, and promotion

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