Manager, Regulatory Affairs

Arbor Biotechnologies™, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimized gene editors unlocks access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need.

About the Role

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 advance 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.

Responsibilities

• 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.

Requirements

• 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.

Preferred Qualifications

• 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.

Location

Hybrid position based in the Cambridge, MA area. Regular on-site presence is expected to support cross-functional collaboration, regulatory planning activities, and key program milestones.

Pay

The anticipated salary range for candidates for this role will be $115,000 - $135,000. The final salary offered will depend on several factors, including relevant years of experience, educational background, industry knowledge, technical skills, and other factors that may prove relevant during the interview process.

Values

• 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.