Director, CMC Regulatory Affairs

Cambridge, MA; Seattle, WA; South San Francisco, CA; Remote-US Based
Feb 05, 2024
Bachelors Degree
Full time

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas.  As a Director, CMC Regulatory Affairs, you will report to the Vice President, CMC Regulatory Affairs and be responsible for leading CMC regulatory strategies across the Sana development portfolio.  Working together with peers within our Technical Operations organization and across the company, you will ensure alignment of product development plans with global CMC regulations and drive the execution of regulatory submissions throughout the product lifecycle.  Cool stuff.

What you’ll do

  • Develop and lead CMC regulatory strategy for programs in Sana’s portfolio of engineering cellular products at all stages, with emphasis on late-stage global development
  • Advise Sana’s CMC teams and cross-functional program teams with critical input on CMC regulatory strategies, risk planning and mitigation, and regulatory interactions
  • Direct strategy development, authoring, review, and integration of CMC content into regulatory submissions: INTERACT meeting documents, Type B/C/D meeting 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
  • Maintain awareness and provide critical expertise regarding global guidelines and requirements pertaining to CMC of engineered cell therapies
  • 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 engineered cell therapies
  • Partner with the VP of CMC Regulatory Affairs in developing tools, templates, and company-wide best practices for CMC regulatory of cell & gene therapies

What we’re looking for

  • D. in a scientific discipline with 8+ years’ related experience in biologics CMC product development, product quality, and/or CMC regulatory affairs; Bachelor’s or master’s degree holders with 10+ years’ related experience may also be considered
  • At least 5 years’ experience in biologics CMC regulatory affairs, including at least 3 years’ experience in CMC regulatory of cell therapies
  • In-depth expert knowledge and understanding of the scientific principles and concepts of cell & gene therapy drug development, relevant CMC regulations, and regulatory guidance
  • 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)

What will separate you from the crowd

  • Experience in CMC regulatory of late-stage and/or commercial-stage engineered cellular therapies
  • Experience in CMC regulatory of CAR T products, allogeneic cell therapies, gene-modified cell therapies, and/or stem cell-based therapies
  • Experience with cell & gene therapy CMC regulatory processes and submissions in markets beyond US and EU (i.e., Canada, UK, Asia), particularly for late-stage programs
  • Experience in CMC regulatory of combination products for cell therapies

What you should know 

  • The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together

  • Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution 

Get to know us

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.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.  For more details on our benefits, visit Sana’s Benefits Portal.

We are 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, social class (including caste/caste identity), 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.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.