Manager, Regulatory Affairs

🔥 1 minute ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $116k - $160k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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

• Support global regulatory activities across early- and late-stage development programs through lifecycle management • Partner cross-functionally to support high-quality regulatory submissions • Help drive successful interactions with global health authorities • Support regulatory strategy and execution for INDs, CTAs, NDA components, supplements, and other product-related regulatory activities • Prepare, review, and submit regulatory filings including INDs/CTAs, amendments and information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures • Assist with coordination and preparation of global health authority meeting documents • Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards • Represent Regulatory Affairs for global study-level activities, including 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 • 4+ years in Regulatory Affairs • Strong knowledge of U.S. and international regulatory requirements for drug development • Excellent verbal and written communication skills • Strong organizational skills • Strong 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

• Equity-based compensation • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan with company match • Life insurance • Flexible spending account for health care and/or dependent care • Annual performance bonus • Long-term incentive plan • Generous parental leave • Family planning benefits • Opportunities for personal and professional growth