Manager, Regulatory Affairs

🕒 May 21

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $116k - $160k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• Support preparation, review, and submission of regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures. • Assist in coordination and preparation of global health authority meeting documents. • Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards. • Represents regulatory for global study-level regulatory activities included but not limited to study start-up, study maintenance, and end of trial activities. • Collaborate with external partners and vendors on regulatory activities and submission support. • Support regulatory operations and continuous improvement initiatives, including work instruction and SOP development and maintenance.

🎯 Requirements

• Bachelor’s degree, preferably in a scientific discipline. • 6+ years of pharmaceutical industry experience, including 4+ years in Regulatory Affairs. • Strong knowledge of U.S. and international regulatory requirements for drug development. • Excellent verbal and written communication, organizational, and cross-functional collaboration skills. • Strong experience in a self-motivated, fast-paced environment. • Experience supporting initial INDs/CTAs, and initial marketing application activities is highly desirable.

🏖️ Benefits

• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.