Associate Director, Regulatory Affairs

Job not on LinkedIn

November 14

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $162.2k - $223k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Deciphera Pharmaceuticals

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Biotechnology • Pharmaceuticals

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.

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage). • Provide solid regulatory solutions and guidance to the cross-functional teams and senior management. • Provide tactical support and operational expertise with “hands on” support as needed. • Assess project plans and timelines. • Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time. • Ensure compliance of regulatory strategies and submissions. • Oversee preparation and review of regulatory submissions and responses. • Monitor regulatory trends and ensure proactive strategy adjustments. • Other duties and responsibilities as assigned.

🎯 Requirements

• B.S/M.S. and 10+ years of work experience in pharmaceutical regulatory affairs • 5+ years of regulatory experience working with global development and submission plans • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU • Must have experience filing INDs and NDAs and engagement with FDA and other regulatory bodies.

🏖️ Benefits

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