Secura Bio was established in 2019 with a singular mission: to close the gap between innovative oncology therapies and the patients who need them most. Our high-touch approach is informed by our decades of experience shaping the impact of oncology’s largest clinical and market opportunities. We know that true impact comes from personalization and an unwavering commitment to serve patients and expand the possibilities of life-prolonging oncology medicines.

REQUIRED QUALIFICATIONS

• Advanced degree (PhD, PharmD, MD) in life sciences, pharmacy, or related field preferred
• 15+ years of progressive experience in regulatory affairs within the biotechnology/pharmaceutical industry
• Expertise in the hematology/oncology field
• Demonstrated track record of successful regulatory submissions and agency interactions
• Comprehensive understanding of FDA, EMA, and other major health authority regulations
• Experience with at least two successful product approvals
• Strong leadership abilities with 8+ years managing regulatory teams
• Excellent communication and interpersonal skills for effective cross-functional collaboration
• Strategic thinking with ability to translate complex regulatory frameworks into practical guidance
• Demonstrated ability to work collaboratively with internal and external stakeholders to achieve consensus in complex and ambiguous situations
• Deep knowledge of GxP requirements and their implementation
• Ability to operate in a fast-paced environment

ABOUT THE ROLE

The Senior Director of Regulatory Affairs serves as a strategic leader responsible for developing and executing regulatory strategies to support product development and commercialization. This senior position oversees all regulatory activities and is responsible for ensuring compliance with global standards and timely product approvals. This position will work closely with outside regulatory subject matter experts, senior leadership, product development, manufacturing, and other external stakeholders to maintain a strong regulatory culture within the organization.

KEY RESPONSIBILITIES

• Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions
• Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries
• Oversee preparation and submission of regulatory documents
• Together with outside regulatory subject matter experts, provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals
• Provide strategic input to leadership on regulatory risk, and inspection readiness, while helping to build and scale the regulatory team
• Interpret and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders
• Collaborate with Quality Assurance to ensure alignment between regulatory requirements and quality systems
• Represent regulatory interests in product development governance committees and decision-making processes
• Stay current with evolving global regulatory requirements and industry trend