Director of Regulatory Affairs (CMC)

Director of Regulatory, CMC

Soufflé Therapeutics is a biotech company focusing on the cell-type specific delivery of genetic medicines. It’s team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-building lab and office space in Watertown. Come and join us in our quest!

Overview

Souffle Therapeutics is seeking a seasoned Director of Regulatory CMC to lead the regulatory CMC strategy to support programs at all stages of the development. Reporting to the Vice President of Regulatory Affairs, this individual will serve as a CMC strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with input and guidance from the team and leadership.

Key Responsibilities

• Lead the development of CMC documentation pertaining to global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests
• Provide authoring support to Manufacturing and Quality team members, including amendments to clinical and commercial manufacturing changes
• Leverage both technical and regulatory knowledge to proactively mitigate risks
• Serves as the Regulatory Affairs CMC representative and point of contact to cross-functional team and participate in team meetings
• Provide support to the Tech Ops and Quality organizations pertaining to meet global product development requirements
• Execute regulatory policies and operational processes to deliver high quality regulatory submissions

Qualifications

• 8 years of experience in regulatory affairs in clinical stage and/or commercial biotech/pharmaceutical company
• Experiences with ADC, antibody, protein conjugate and rare disease are preferred.
• Solid understanding of FDA guidance, EU regulations, ICH guidelines and eCTD submission
• Thorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends
• Ability to work independently to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones
• Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management
• Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detail
• Recognized as a leader, team player, and possess a cross-functional collaborative skill set

Education

• Minimum of a bachelor’s degree in life science is required.

At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. We share the pay range for this specific role with the actual base salary reflected in criteria such as job-related knowledge, skills, market factors, and experience:

$230,000 - $283,000 a year 20% annual bonus.

This is an onsite position in Watertown, MA with flexibility as needed for collaboration and external engagements.

We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.