Manager, Regulatory Affairs

Arbor Biotechnologies, a clinical stage, next-generation gene editing company based in Cambridge, MA, is advancing a portfolio of first-in-class genomic medicines addressing serious diseases for which there are no existing functional cures, with a CNS pipeline initially prioritizing multiple ALS targets and a co-developed, clinical program, ABO-101, for the treatment of primary hyperoxaluria type 1. The company’s unique breadth of gene editing technologies goes beyond the limitations of early editing approaches to unlock access to new gene targets and expand the therapeutic reach of genomic medicines. For more information, please visit: arbor.bio.

Passionate, determined, and accountable. Curious, resourceful, innovative, forward thinking, and resilient. Authentic, humble, open-minded and puts team above self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!

Arbor Biotechnologies is seeking a Manager, Regulatory Affairs, to support an expanding portfolio of gene editing programs. Reporting to the Director of Regulatory Affairs, this individual will support regulatory execution across internal and partnered development programs, health authority interactions, and cross-functional activities to support advancement of multiple programs toward IND/CTA submission. 

This role is ideal for a collaborative, scientifically minded regulatory professional who thrives in a fast-paced biotechnology environment.

• Coordinate preparation and execution of regulatory submissions, including health authority meeting packages, IND/CTA amendments, annual reports, future IND/CTA submissions, and associated submission planning and readiness activities.
• Partner with Clinical, CMC, Nonclinical, Quality, and Program Management teams, as well as external partners, to support execution of regulatory milestones.
• Coordinate document review cycles, submission readiness activities, and cross-functional regulatory deliverables.
• Maintain regulatory timelines, trackers, submission plans, and regulatory commitments.
• Manage RIMS/document repositories, compliance records, and inspection-ready regulatory documentation.
• Ensure regulatory documentation meets internal quality standards and audit/inspection readiness requirements.
• Support health authority interactions through meeting logistics, correspondence tracking, and follow-up activities.
• Coordinate activities with publishing, medical writing, and regulatory vendors to ensure timely delivery of regulatory documents and submissions.
• Contribute to development and continuous improvement of regulatory SOPs and processes
• Provide regulatory process guidance to cross-functional partners
  
  

• Bachelor’s degree in a scientific discipline.
• 5-7 years of experience in biotechnology or pharmaceutical drug development, including experience supporting Regulatory Affairs or regulatory activities for investigational products.
• Experience supporting INDs and/or early-stage development programs.
• Experience supporting FDA meetings and regulatory submissions.
• Experience managing multiple concurrent regulatory deliverables/timelines under supervision of senior regulatory leadership
• Strong understanding of the drug development process and cross-functional development teams.
• Excellent scientific writing, communication, planning and organizational skills.
• Demonstrated ability to work independently, prioritize effectively, and drive regulatory deliverables in a dynamic environment. 

• Experience in mRNA, RNAi, gene therapy, or CRISPR/gene editing therapeutics.
• Experience working with external development or commercial partners.
• Experience with RIMS (e.g., Kivo, Veeva).
• Experience in a small or emerging biotechnology company with rare or genetic disease focus.

Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us! 

• Purposeful Action: Driven by outcomes, guided by purpose
• Bold Resilience: Speak boldly, embrace change, grow forward
• Humble Authenticity: Be real, value the uniqueness of others, elevate all

The anticipated salary range for candidates for this role will be $115,000 - $135,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, industry knowledge, technical skills, and other factors that may prove relevant during the interview process.

We promote diversity and inclusion not just in our recruitment processes, but in everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.