Senior Director Regulatory Affairs Clinical

JOB PURPOSE

Here at Sana, we are seeking a Senior Director / Executive Director Regulatory Affairs Clinical. Reporting to the Head of Regulatory Affairs and Strategy, the incumbent plays an important role to provide regulatory guidance and prepare successful regulatory submissions as Sana transitions from pre-clinical stage to clinical stage. This position will be responsible for implementing and advising on global regulatory strategies, processes, and procedures for Sana's development programs to ensure the latest requirements and standards are met, and to deliver exceptional results and ensure long-term success.

DUTIES AND RESPONSIBILITIES

• Assist with, or oversee, the development and implementation of regulatory strategy, procedures, and processes
• Provide Sana's cross-functional program teams with critical assessment and input on regulatory strategies, risk planning and mitigations, critical issue management, and advice on regulatory interactions
• Strategize and manage the preparation and timely submission of regulatory documentation to support investigational and marketing application packages globally
• Represent Sana in meetings with regulatory agencies / authorities; oversee the preparation of meeting documents (e.g., requests, meeting packages); and strategize, prepare for meetings, teleconferences, and other communications (e.g., Sana's responses to information requests) with FDA and other regulatory agencies / authorities
• Provide leadership on regulatory interactions and negotiation with global regulatory agencies / authorities to resolve key regulatory issues critical to the successful development of Sana's cell and gene therapy portfolio
• Stay well informed of global regulatory environment and assess its impact of changes on Sana's development programs
• Maintain the expertise with the most updated knowledge on regulations and regulatory guidance documents from global regulatory agencies / authorities such as FDA, EMA, ICH; make high-quality regulatory recommendations to Sana's senior leadership and cross-functional teams; and ensure adherence to these regulatory guidance and regulations as well as Sana's internal procedures
• Assist the Head of Regulatory Affairs and Strategy with long and short-term departmental planning including structure, headcount, budgeting, training, and systems requirements
• Manage external regulatory vendors / consultants as needed
• Demonstrate Sana's core values and the attributes that support these core values (Lead from every seat, Thrive as a team, Make it happen)

QUALIFICATIONS

Basic Qualifications

• Bachelor's degree in life sciences. Advanced degree (e.g., MD, PhD, PharmD or MS) preferred.
• More than 10 years of biotechnology or pharmaceutical industry experience, preferably at least 5 years of cell and / or gene therapy experience
• In-depth and comprehensive knowledge and understanding of drugs / biologics development process, regulatory requirements, regulations and regulatory guidances
• Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, and product lifecycle management
• Rich and demonstrated skills and experience in interactions with regulatory authorities.
• Track record of significant regulatory accomplishments such as IND submissions that have progressed to final approval
• Excellent writing, interpersonal communications, organizational, and presentation skills
• Established leadership and management skills with cross-functional teams in a matrixed organizational structure
• Demonstrated experience with budgeting and planning
• Strong leadership, strategic orientation, development of people, and process