Senior Director Regulatory Affairs Clinical

Location
Seattle, South San Francisco, CA, United States
Posted
May 24, 2021
Ref
5161288002
Required Education
Bachelors Degree
Position Type
Full time
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
  • 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
  • Working safely in person on a predictable and regular in-person basis is an essential job function for this position and the Company requires that all individuals working in-person, subject to certain exceptions, be fully vaccinated against COVID-19.


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The job description listed above is representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

The Company is committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. We cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short and long term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.