Director, CMC Regulatory Affairs

Location
Seattle, South San Francisco, CA, United States
Posted
Jul 04, 2021
Ref
5045136002
Required Education
Bachelors Degree
Position Type
Full time
JOB PURPOSE

Sana Biotechnology is looking to grow its team with hard-working individuals who believe in the potential of cells as engineered medicines, have an innovative vision, and have the determination to execute that vision. As Director, CMC Regulatory Affairs, the chosen candidate will be responsible for developing and implementing CMC regulatory strategies for Sana's portfolio of in vivo and ex vivo products. Working together with peers within our Technical Operations organization and cross-functionally across the company, the successful candidate will ensure alignment of product development plans with global CMC regulations and drive the execution of regulatory submissions throughout the whole product lifecycle.

DUTIES AND RESPONSIBILITIES
  • Develop and implement CMC regulatory strategy for programs in Sana's portfolio of in vivo and ex vivo engineered cellular products at all stages, from preclinical to post-licensure
  • Provide Sana's CMC teams and cross-functional program teams with critical input on CMC regulatory strategies, risk planning and mitigation, and advice on regulatory interactions
  • Oversee the strategy development, authoring, review, and integration of CMC content into regulatory submissions: INTERACT meeting documents, Type B/C and Scientific Advice briefing packages, IND/CTAs, and BLA/MAAs
  • Partner with peers in Clinical Regulatory Affairs to drive effective communication with global regulatory authorities and represent Sana on key CMC issues at regulatory meetings and teleconferences
  • Actively engage in external CMC policy efforts, including industry working groups, scientific forums, and non-profit organizations to shape the regulatory environment for the manufacturing, analysis, and development of gene and cell therapies
  • Maintain awareness and provide critical expertise regarding FDA and EU guidelines related to CMC topics
  • Partner with the VP of CMC Regulatory Affairs in developing tools, templates, and company-wide best practices for CMC regulatory of cell & gene therapies
  • Manage external regulatory 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 with equivalent experience considered with a minimum of 10 years' related experience in biologics CMC product development, product quality, and/or CMC regulatory affairs; at least 3 years' experience in CMC regulatory
  • In-depth, comprehensive knowledge and understanding of the cell & gene therapy drug development process, relevant CMC regulations, and regulatory guidances
  • Demonstrated success in developing CMC strategy, overseeing authoring of CMC content for regulatory submissions (INTERACT, pre-IND, IND, BLA), and interacting with regulatory authorities in US and Europe
  • Exceptional written and spoken communications, strong presentation skills
  • Track record of effective cross-functional leadership and excellent teamwork; ability to manage up, down, and across a dynamic, science-oriented organization
  • Ability to work, influence, and gain consensus across multiple functions (R&D, PD, Manufacturing, Regulatory, Quality, and Clinical)
  • Ability to deliver results consistently, capably manage near-term and long-term priorities, and quickly adapt to changing business conditions
  • Demonstrated commitment to contribute to a culture that aligns with Sana's core values and leverages diverse perspectives and experiences
  • Must be highly organized and have the ability to manage multiple initiatives with many stakeholders
  • Proven track-record to collaborate effectively in a cross-functional matrix environment and lead through influence across functional and organizational lines
  • Strong analytical, problem solving, critical thinking and decision-making skills
  • Proven track-record adapting to increasing scope and complexity of work brought on by growth/change and managing through change and ambiguity
  • Ability to engage in crucial conversations - providing and receiving feedback
  • 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.

Preferred Qualifications
  • Advanced degree in a life science preferred (e.g., PhD, MS);
  • Experience in CMC regulatory of cellular therapies and/or gene-modified cellular therapies is strongly preferred; experience in CMC regulatory of in vivo gene therapies is a plus
  • Experience in CMC regulatory of devices and combination products for cell and/or gene therapies
  • Experience with cell & gene therapy CMC regulatory processes and submissions in markets beyond US and Europe is desirable (i.e., Canada, Japan, China)

WORKING CONDITIONS

This position may be located in Sana's offices in Seattle, South San Francisco, or Cambridge, and will report directly to the VP, CMC Regulatory Affairs.

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.