Director, Global Regulatory Affairs

🕒 October 5

🏄 California – Remote

🏄 California – Remote

💵 $180k - $230k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

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Angitia Biopharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2018

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

💰 $46M Series B on 2023-10

Healthcare • Consulting • Biotechnology

Angitia Biopharmaceuticals is a clinical-stage biotechnology company founded in 2018, focused on the discovery and development of breakthrough therapeutics for serious musculoskeletal diseases. With a strong emphasis on innovation, Angitia aims to address unmet medical needs through their pipeline of therapeutics, including treatments for conditions such as Osteogenesis Imperfecta and Osteoarthritis. The company is devoted to fostering a culture of respect and equality, and is committed to employee growth and career development while delivering effective therapies to help patients in need.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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