Director, Regulatory Affairs

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $196k - $245k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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This company has sponsored H1B visas in the past.

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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

• Serve as regulatory lead for assigned oncology programs, developing and implementing regulatory strategies from FIH through post-marketing stages • Provide regulatory input to clinical and development teams to ensure strategic alignment across functions • Monitor and interpret global regulatory trends and communicate potential program impacts to senior leadership • Lead preparation and submission of INDs, NDAs, and other regulatory filings • Ensure submissions are high quality, compliant, and meet global regulatory expectations • Provide hands-on operational oversight for submission preparation, review, and delivery • Collaborate with Clinical Development, Clinical Operations, Quality, and CMC teams • Provide regulatory advice to project teams and senior management • Represent Regulatory Affairs at internal and external meetings, including interactions with regulatory authorities • Guide and mentor Regulatory Affairs staff • Assess team resources and project priorities to ensure timely delivery of key milestones • Promote a collaborative, solutions-oriented culture within Regulatory Affairs • Contribute to continuous improvement initiatives and implement processes to increase regulatory efficiency • Leverage prior project learnings to optimize global regulatory submissions and strategies • Foster innovation and strategic thinking in regulatory planning and execution • Perform other duties and responsibilities as assigned

🎯 Requirements

• B.S. or M.S. in a scientific discipline • Minimum of 12 years of experience in pharmaceutical Regulatory Affairs • Advanced knowledge and experience interpreting regulations, guidelines, and precedents related to oncology drug development in the US and EU • Proven track record in preparing and submitting INDs, NDAs, and other major regulatory filings • Experience engaging with FDA and other global regulatory agencies • Ability to lead and manage multiple complex projects simultaneously • Excellent written, verbal, and interpersonal communication skills • Strategic thinking and ability to anticipate regulatory challenges and propose innovative solutions • Experience working in oncology drug development at a small-to-midsize biotechnology company • Strong leadership and mentorship skills with a collaborative approach • Ability to thrive in a fast-paced, cross-functional environment • Detail-oriented, proactive, and results-driven mindset

🏖️ 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 • Long-term incentive plan • Other incentive compensation plans (if applicable)

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