Senior Vice President, Regulatory Affairs

Job Summary 

Reporting to the CMO, the ideal candidate will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for product development and approval, in alignment with the global business strategy. Responsible for leading a comprehensive and strategic approach to developing and executing integrated global regulatory strategies that account for the complex interplay between major Health Authorities. Represent the company with domestic and international regulatory authorities, contractors, and corporate partners. Provide regulatory support for various departments, projects, and teams/committees.

Primary Responsibilities 

• Direct Keros’ global clinical, non-clinical, and CMC regulatory strategies
• Provide regulatory guidance throughout the development process
• Oversee clear and effective regulatory submissions on behalf of Keros leveraging internal and external resources
• Oversee meetings with regulatory bodies to include but not limited to Pre-IND meetings, Type C meetings, EOP meetings, pre-NDA meetings, and EU Scientific Advice
• Build and maintain excellent relationships with relevant regulatory agencies
• Review, analyze and translate regulatory requirements into a workable deliverable for project meetings, senior and executive management decisions
• Supervise, interact with and/or coordinate with regulatory team and external service providers to ensure adequacy of project support and deliverables
• Supervise, review, and edit regulatory documents and packages for submissions to national regulatory authorities (NRAs) and/or scientific or executive management meetings
• Build the Regulatory and Medical Writing functions that can support clinical trials to product registration
• Conversant with all aspects of the external regulatory environment, including upcoming regulations and regulatory positions, thereby providing the company with the necessary regulatory technical expertise and counsel to ensure success in developing its products
• Review and edit, as appropriate, press releases, presentations for external meetings

Qualifications 

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements for early and late-stage development programs
• Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project
• Solid knowledge of GCPs and GLPs
• Direct experience in interfacing with relevant regulatory authorities
• Experience working in a small biotech company environment for 5+ years
• Regulatory experience in rare/ultra-rare diseases
• Demonstrate excellent leadership and communication skills
• Demonstrate strong organizational skills, including the ability to prioritize personal workload
• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
• Experience with eCTD, e-publishing systems for preparing regulatory submissions

Education Requirements 

• Advanced degree (PhD, PharmD, MD, or equivalent) in a relevant scientific discipline
• 15+ years of progressive regulatory affairs experience in biopharmaceuticals, with at least 10 years in rare disease