Job Details

Senior Director/Vice President, Regulatory Affairs

Cambridge, MA

Position Summary

Orbital Therapeutics is seeking a dynamic and experienced Senior Director/Vice President of Regulatory Affairs to lead the company's regulatory strategy and advise on the company's quality strategy and operations. This individual will oversee regulatory submissions to global health authorities and ensure compliance with evolving regulatory frameworks. The ideal candidate will have deep expertise in regulatory affairs and complementary experience in quality assurance and control within the biotechnology or pharmaceutical industry.

Responsibilities:

• Develop and implement comprehensive regulatory strategies to support the advancement of Orbital's RNA-based therapies from early development to commercialization.
• Facilitate and drive communication with the FDA, EMA, and other global regulatory agencies to ensure proactive and effective interactions.
• Manage the preparation, submission, and maintenance of regulatory filings, including INDs, CTAs, BLAs, and NDAs.
• Collaborate cross-functionally with clinical, CMC, and research teams to ensure alignment of regulatory and quality strategies.
• Establish and maintain a culture of quality and compliance by overseeing the development and implementation of internal regulatory and quality processes and procedures including SOPs and a robust quality management system (QMS) to ensure global regulatory and quality compliance.
• Ensure regulatory oversight of clinical trials to guarantee compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) standards.
• Stay abreast of evolving global regulatory landscapes and proactively address potential challenges and opportunities.
• Conduct regulatory due diligence for potential partnerships, licensing opportunities, and other business development opportunities.
• Mentor and develop a high-performing regulatory and quality team.

Qualifications:

• Advanced degree in a relevant scientific discipline (PhD, PharmD, MS) preferred.
• 12+ years of experience in regulatory affairs within the biopharmaceutical industry, including leadership roles.
• Proven track record of successful interactions with global regulatory authorities and leading regulatory submissions.
• Experience in RNA-based or gene therapy products is highly desirable.
• Strong understanding of quality systems and regulatory compliance in drug development.
• Experience working within a small biotech company environment.
• Excellent leadership, communication, and strategic problem-solving skills.
• Ability to work in a fast-paced, innovative, and collaborative environment.