Job Details

Overview

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

Vice President / Head of Regulatory Affairs

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 role requires extensive experience in both large and small pharmaceutical organizations and the ability to navigate the regulatory landscape. The ideal candidate will have strong leadership, a strategic mindset, and a proven track record of successful regulatory submissions.

Nura Bio offers a comprehensive benefits package including medical and dental insurance, vision, life and disability insurance, health savings account, flexible spending, dependent care, 401(k), and attractive stock options. Nura Bio is 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 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 in joining us to ...@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.

Employment details

• Employment type: Full-time
• Seniority: Not Applicable
• Job function: Legal
• Industries: Biotechnology

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