Manager, Regulatory Affairs

Arbor; Cambridge (MA); On-site; USD 115,000 - 135,000; Full time

Job summary

Arbor Biotechnologies, based in Cambridge, MA, is seeking a Manager, Regulatory Affairs, to support regulatory execution across internal and partnered programs, health authority interactions, and cross-functional activities toward IND/CTA submissions. You will lead regulatory milestones with Clinical, CMC, Nonclinical, Quality, and Program Management partners in a fast-paced biotech environment.

The ideal candidate has 5–7 years in biotech or pharma, experience with INDs and FDA meetings, and

Qualifications

• Bachelor’s degree in a scientific discipline required.
• 5–7 years in biotechnology/pharma drug development with regulatory experience.
• Experience supporting INDs, FDA meetings, and regulatory submissions.

Responsibilities

• Coordinate regulatory submissions, meeting packages, IND/CTA amendments, annual reports and submission planning.
• Partner with Clinical, CMC, Nonclinical, Quality and Program Management teams and external partners.
• Coordinate document reviews, submission readiness activities, and cross-functional deliverables.
• Maintain regulatory timelines, trackers, submission plans and commitments.
• Manage regulatory document repositories and inspection-ready materials.
• Support health authority interactions through logistics, tracking and follow-up.
• Coordinate with publishing, medical writing and regulatory vendors for timely documents.
• Contribute to SOP development and process improvements.
• Provide regulatory guidance to cross-functional teams.

Skills

Scientific writing

Communication

Planning

Organization

Regulatory affairs

Education

Bachelor's degree in a scientific discipline

Tools

RIMS (Kivo, Veeva)

Job description

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 goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need. With Arbor’s lead program, ABO-101 for the treatment of primary hyperoxaluria type 1, progressing into clinical trials, the company continues to focus their research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures. For more information, please visit: arbor.bio.

Who Are You?

You’re driven by purpose and fueled by curiosity. You take ownership, think boldly, and stay resilient through challenge. You lead with humility, value diverse perspectives, and put the success of the team above personal recognition.

That’s who thrives at Arbor. If this resonates, read on.

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 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.

What You Can Expect

• 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

What You Bring

• Bachelor’s degree in a scientific discipline.
• 5-7 yearsof 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

• 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.

Our Values

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.