Senior Director, Global Regulatory Affairs

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September 26

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Enliven Therapeutics

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Enliven Therapeutics is a company dedicated to developing innovative solutions for cancer treatment. They focus on creating small molecule kinase inhibitors designed to improve efficacy, safety, and patient convenience. With programs targeting BCR-ABL, HER2, and additional pathways, Enliven Therapeutics aims to enhance the precision and selectivity of cancer therapeutics, combat resistance, and address brain metastases. The company prides itself on a team of experienced drug developers and aims to help cancer patients live longer and better lives.

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Leads project teams in implementing and delivering the regulatory strategy across multiple early and/or late-stage programs • Develop Regulatory Strategy for complex programs in oncology • Participates in cross-functional teams as regulatory project lead, providing regulatory strategic guidance and support • Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans • Drives health authority interactions, including planning, briefing material development, and meeting preparation leadership • Monitors changes in the regulatory environment, both general and specific to the therapeutic area and supports and advises Development Teams accordingly • Independently executes preparation, submission, and maintenance of regulatory applications, including initial applications, routine amendments, annual reports, IND safety reports, and correspondence with global Health Authorities • Partners with external vendors in support of regulatory document preparation and submission • Leads and executes non-project regulatory activities • Demonstrates capability and credibility in complex, business critical projects as well as ability to cope with ambiguity and manage key stakeholders.

🎯 Requirements

• MD/DO degree with 5+ years of drug development experience, with 3+ years acting as a safety medical monitor in industry • Board certification in oncology is preferred • Demonstrated expertise in medical evaluation and safety surveillance, ideally in nephrology or immunology therapeutic areas • In-depth understanding of pharmacovigilance data, including clinical and post-marketing safety information • Well-versed in global drug safety regulatory frameworks, including ICH guidelines, 21 CFR, and EU GVP requirements for investigational products • Hands-on experience with safety data analysis, MedDRA coding, and adherence to international PV standards and practices • Highly organized and adaptable, with strong written and verbal communication skills • Proven ability to manage cross-functional collaborations, lead discussions on safety strategy, and resolve complex patient safety concerns • A “can do” attitude and ability to operate in a fast-paced startup environment

🏖️ Benefits

• $270k - $330k. A discretionary annual bonus may be available based on individual and Company performance.