Director – Regulatory Affairs

Director – Regulatory Affairs

Requirements

• In-depth and robust knowledge of the drug development process, pharmaceutical industry, health authority regulations, healthcare environment and policies.
• Highly skilled in the development and management of multinational IND and clinical trial applications throughout the product development lifecycle, with a proven track record of significant regulatory accomplishments.
• Ample experience leading teams in the preparation of health authority applications and health authority interactions.
• Reliable and collaborative leader, who is skilled in devising pragmatic solutions while navigating challenging situations.
• Accustomed to independently providing regulatory leadership and guidance on cross-functional teams and working in a matrixed environment.
• Well-versed in the evaluation of complex scientific information and regulatory guidelines, with a demonstrated ability to formulate recommendations based on assessment.
• Effective communication skills with a demonstrated ability to influence decision-making and/or deliver comprehensive recommendations in written or verbal presentation format.
• Possess strong scientific and business acumen, capable of strategic thinking, planning, and proposing innovative solutions to regulatory challenges.
• BA/BS degree in biological/physical sciences required. Advanced degrees preferred.
• 10+ years relevant Regulatory Affairs experience in the biotechnology or pharmaceutical industry or a combination of education and experience
• Experience in autoimmune disease and/or hematology/oncology development
• Experience with document management and Regulatory Information Management (RIM). Veeva Vault experience preferred.
• Proficient with MS Office tools to perform project management, tracking, writing and presentation tasks.

Responsibilities

• Serve as the global regulatory lead, who is responsible for providing strategic and operational regulatory guidance to development teams including (but not limited to) global submission plans, US/EU or other national clinical trial requirements, and health authority interaction leadership.
• Represent Cullinan as the primary point of contact for regulatory authorities and/or contracted regulatory representatives (e.g., CRO local representative).
• Proactively communicate potential regulatory issues and mitigation strategies by facilitating and/or contributing to risk assessments and managing critical issues.
• Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial / marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.
• Lead high-quality, on-time regulatory submission execution (IND/CTA/NDA/MAA, as applicable) in compliance with applicable regulatory requirements in a fast-paced matrixed environment, and in alignment with corporate goals.
• Actively lead or participate in regulatory department infrastructure and capability building, including best practices, templates, training tools, and cross-program knowledge sharing.
• Support due diligence and strategic partnering activities, as needed.
• Provide mentorship and coaching to regulatory colleagues to foster a supportive and growth-minded culture.
• Perform duties in accordance with Cullinan’s core values, policies and all applicable regulations.

Preferred Qualifications

• Advanced degrees preferred.
• Veeva Vault experience preferred.