Nura Bio

Nura Bio, Inc. (Nura Bio) is a clinical-stage biopharmaceutical company developing neuroprotective therapies for the treatment of a broad range of neurological diseases. Nura Bio’s research and early development small molecule pipeline is focused on developing therapies that halt axon degeneration and/or modulate microglial responses to degeneration and injury, with the goal of conferring neuroprotection, across diseases of the central, peripheral, and ocular nervous system.

The VP/Head of Regulatory Affairs will be a key member of our clinical leadership team, responsible for developing and executing regulatory strategies to support the company's product development and commercialization goals. Reporting to the Chief Medical Officer. This individual will have extensive experience in both large and small pharmaceutical organizations and will leverage their expertise to navigate the complex regulatory landscape. The ideal candidate will possess strong leadership skills, a strategic mindset, and a proven track record of successful regulatory submissions.

Nura Bio offers a comprehensive generous medical and dental insurance, vision, life and disability insurance, health savings account, flexible savings, and dependent care, 401(k) plan, and highly attractive stock options.

Nura Bio is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

To learn more about our mission and our science, visit us at www.nurabio.com. If you have the experience we are seeking and would like the opportunity to contribute to our mission, we would like to hear from you!

Please send your CV with a cover letter delineating why you are interested to joinus@nurabio.com

What You Will Do:

• Develop and implement comprehensive regulatory strategies to ensure timely approval of new products and maintain compliance with regulatory requirements.
• Lead interactions with regulatory agencies, including the FDA, EMA, and other global health authorities, to facilitate the approval process.
• Lead regulatory planning and submission activities, including authoring or overseeing the preparation of INDs, CTAs, briefing packages, orphan/RMAT designations, and other early-phase regulatory filings.
• Provide regulatory guidance and support to cross-functional teams, including research and development, clinical, manufacturing, and quality assurance.
• Monitor and interpret regulatory changes and trends and communicate their impact on company operations.
• Collaborate with external partners, consultants, and contractors to ensure alignment with regulatory requirements.
• Mentor and develop the regulatory affairs team, fostering a culture of continuous learning and professional growth.
  
  
  

What You Will Bring:

• Advanced degree in a relevant scientific discipline (e.g., PharmD, PhD, MD).
• 12+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Experience working in CNS/neurological development programs is preferred.
• Demonstrated experience in both large and small pharmaceutical organizations.
• In-depth knowledge of global regulatory requirements and guidelines.
• Proven track record of successful regulatory submissions and product approvals.
• Strong leadership and project management skills, with the ability to work effectively in a fast-paced, dynamic environment.
• Excellent communication and interpersonal skills, with the ability to influence and build relationships at all levels of the organization.
• High attention to detail and strong problem-solving abilities.