Director, Global Regulatory Affairs

🕒 3 dias atrás

🏄 California – Remoto

🏄 California – Remote

💵 $180.000 - $230.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Angitia Biopharmaceuticals

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2018

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

💰 $46.000.000 Series B em 2023-10

Healthcare • Consulting • Biotechnology

Angitia Biopharmaceuticals é uma empresa de biotecnologia em estágio clínico fundada em 2018, focada na descoberta e desenvolvimento de terapias inovadoras para doenças musculoesqueléticas graves. Com um forte enfoque na inovação, a Angitia busca atender necessidades médicas não satisfeitas por meio de seu pipeline de terapias, incluindo tratamentos para condições como Osteogênese Imperfeita e Osteoartrite. A empresa se dedica a promover uma cultura de respeito e igualdade, e está comprometida com o crescimento e desenvolvimento de carreira dos colaboradores, enquanto oferece terapias eficazes para ajudar pacientes necessitados.

Descrição

• Lead the development and execution of global regulatory strategies for assigned development programs • Lead the product's Global Regulatory Team and represent Regulatory Affairs on governance and cross-functional development teams • Provide regulatory leadership across nonclinical, clinical, CMC, registration, and lifecycle management activities • Partner with cross-functional teams to shape development plans, study designs, endpoints, and regulatory pathways • Identify regulatory risks and opportunities and develop mitigation and management recommendations • Lead regulatory strategy and execution for health authority interactions, including meeting preparation, briefing materials, and responses • Provide strategic oversight and direction of major regulatory submissions, including INDs, CTAs, amendments, and marketing applications • Direct global and regional submission strategies with regional regulatory stakeholders • Ensure regulatory submissions are scientifically sound, strategically aligned, and high quality • Monitor evolving regulatory requirements and assess their impact on development programs • Build and maintain relationships with regulatory authorities, consultants, contractors, and partners • Influence cross-functional teams to achieve program objectives while balancing regulatory and business considerations • Mentor junior regulatory professionals and contribute to departmental initiatives, process improvements, and capability development • Provide regulatory recommendations and strategic input to senior management and governance committees • Maintain a global perspective and promote alignment across programs, regions, and functional areas

🎯 Requisitos

• Bachelor's degree in Life Sciences or related discipline; advanced degree preferred (PharmD, MS, PhD, MBA, or equivalent) • 10+ years of pharmaceutical or biotechnology experience, including at least 8 years in Regulatory Affairs strategy • Significant experience supporting global development programs through registration and lifecycle management • Strong knowledge of regulatory requirements and frameworks in the US, EU, and Japan • Experience leading interactions with health authorities, including FDA, EMA, and PMDA • Experience developing major regulatory submissions and regulatory strategies • Experience in rare disease, orphan drug development, or other specialized development pathways is preferred but not required • Demonstrated ability to lead and influence cross-functional matrix teams • Strong strategic thinking, problem-solving, and decision-making skills • Excellent communication, presentation, and interpersonal skills • Strong organizational skills and ability to manage multiple priorities • Experience working in multinational and multicultural environments

🏖️ Benefícios

• Medical, dental, and vision coverage for employees and their eligible dependents • 401(K) Retirement Plan with Company match • Company paid Long Term Disability Coverage • Company-paid life Insurance & AD&D Coverage • Voluntary Life Insurance & AD&D Coverage • Employee Assistance Program (EAP) • Company-paid Holidays • Vacation • Paid Sick Leave • Telecommunication Monthly Stipend • Work-From-Home Equipment Reimbursement