Director/Sr. Director of Regulatory Affairs

SQZ Biotechnologies is seeking a Director/Sr. Director of Regulatory Affairs to act as the senior regulatory strategist supporting our early to late phase clinical assets. This is an exciting opportunity to step into a newly created role reporting directly into SQZ’s Chief Medical Officer. The selected individual will be responsible for leading, through cross-functional collaboration, the development, planning, and execution of SQZ’s regulatory strategy to facilitate the achievement of the company’s short and long-term objectives

At SQZ, we're proud of our culture and always look to grow our team with people who share our values. We:

  • Squeeze Together: We value teamwork, trust, and transparency as critical components for achieving our mission and exceeding our goals 
  • Question Boundaries: We’re committed to questioning the status quo and changing the world through our people and our science
  • Zap Obstacles: We strive to be pioneers. We’re resilient when it comes to navigating challenges, anticipated or not, scientific and otherwise

Key Responsibilities:

  • Lead, develop and implement regulatory strategy to meet company goals and objectives 
  • Provide regulatory oversight and guidance to project teams on compliance matters, health authority requirements, and clinical study design issues, logistics, and operational recommendations for product development 
  • Accountable for the development and submission of regulatory documents (e.g., pre-IND and end-of-phase briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory queries, IND safety reports, etc.) 
  •  Facilitate problem-solving and drive decision-making around complex regulatory, preclinical, clinical and CMC development issues by program teams
  • Work proactively in a cross-functional organization to partner with various other functions to plan and execute an effective regulatory strategy in alignment with the overall clinical development plan
  • Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions 
  • Ongoing management of the regulatory strategy including effectively communicating deliverables to program team and proactively drive teams and external vendors to meet the designated timelines for deliverables
  •  Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks 
  • Supervise and mentor direct reports 


Minimum Basic Qualifications:

  • Bachelor’s degree in life sciences with 10 years industry experience of which 8 years include regulatory experience
  • Successful submission, approval, and post-approval management of an NDA/MAA/NDS in multiple ICH regions 
  • Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products in multiple ICH regions;
  • Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills
  • Demonstrated Strategic Thinking – Capable of strategic thinking and proposing innovative solutions to regulatory problems
  • Strong influencing and negotiation skills
  • Excellent oral and written communications skill


Preferred Qualifications and Experience:

  • Advanced technical degree MSc or Ph.D. is preferred in life sciences 
  • Regulatory Affairs Certification (RAC) is preferred
  • Experience in immune oncology possibly cell therapy is preferred

SQZ Biotechnologies is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, SQZ complies with applicable state and local laws governing nondiscrimination in employment. Local candidates only please.

 

Remind me to apply later

Want to apply later?

Type your email address below to receive a reminder

ErrorRequired field

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file