A bachelor's degree in life sciences or a related discipline is required.
At least 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience.
Demonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for preclinical and/or early clinical development programs.
Strong written and verbal communication skills, including the ability to synthesize complex scientific data into clear regulatory narratives.
Ability to operate effectively and independently in a fast-paced, early-stage development environment.
Responsibilities
Lead regulatory strategy and execution for development programs across the portfolio, spanning preclinical and early clinical stages.
Serve as Global Regulatory Lead on cross-functional program teams for development programs across the portfolio.
Develop, maintain, and execute program-level regulatory strategies aligned with corporate objectives and stage of development.
Define regulatory pathways, designation opportunities, and submission sequencing in collaboration with cross-functional stakeholders.
Identify regulatory risks and develop mitigation strategies aligned with clinical, nonclinical, and CMC development plans.
Provide regulatory input into development plans to support preclinical programs and early clinical development, with strategies informed and refined through ongoing execution.
Serve as the primary regulatory point of contact with the FDA and other global health authorities, including MHRA and EMA.
Lead strategic planning and preparation for regulatory interactions, including early advice engagements, platform discussions, and informal and formal agency meetings.
Develop regulatory questions, meeting objectives, and overall regulatory positioning to guide health authority engagement and inform development decisions.
Lead development of health authority briefing packages by establishing the regulatory framework, key messages, and data narrative, and contributing to authoring with subject matter experts and medical writers.
Document, interpret, and integrate health authority feedback into regulatory and development strategy, and coordinate responses to health authority requests.
Author and lead preparation of regulatory designation applications, such as Orphan Drug, Rare Pediatric Disease, Fast Track, and other applicable expedited programs.
Develop supporting regulatory rationale and cross-functional data narratives for designation requests.
Manage submission, agency correspondence, and follow-up related to regulatory designations.
Lead cross-functional planning of regulatory submissions and amendments, including FDA IND submissions, and provide regulatory oversight of CRO-led regulatory activities and submissions outside the United States.
Ensure regulatory alignment across clinical, nonclinical, and CMC components of submissions.
Lead cross-functional planning and alignment for ongoing lifecycle management activities, including annual reports and DSURs, leveraging CRO partners for execution.
Provide regulatory review and oversight of deliverables prepared by CROs and external vendors to ensure quality, consistency, and compliance.
Provide regulatory guidance to leadership to inform development and regulatory decision making.
Collaborate with external regulatory consultants as strategic advisors to support regulatory positioning and health authority interactions.
Oversee and coordinate medical writing support and submission vendors for regulatory documents.
Ensure alignment between internal teams and external partners to support submission timelines.
Desired Qualifications
An advanced degree is preferred.
Experience leading FDA interactions and/or IND submissions is preferred.
Experience with biologics, gene therapy, or gene-editing products is preferred.
Who are we?
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.
Who are you?
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!
Why this role matters.
The Director of Regulatory Affairs is responsible for leading regulatory strategy and execution for Abror’s development programs across the portfolio, spanning preclinical and early clinical stages. Reporting to the VP, Head of Clinical Development, this role serves as the Global Regulatory Lead on cross functional program teams and as the primary regulatory point of contact with FDA and other global health authorities.
The Director provides regulatory guidance to support development decision making and leads regulatory strategy through planning, execution, and health authority engagement appropriate to the stage of development. The role also translates regulatory strategy into actionable submissions, briefing materials, and agency interactions in collaboration with internal subject matter experts, external development partners, CROs, medical writers, and regulatory consultants.
What you'll own.
Regulatory Strategy & Program Engagement
Serve as Global Regulatory Lead on cross functional program teams for development programs across the portfolio.
Develop, maintain, and execute program level regulatory strategies aligned with corporate objectives and stage of development.
Define regulatory pathways, designation opportunities, and submission sequencing in collaboration with cross functional stakeholders.
Identify regulatory risks and develop mitigation strategies aligned with clinical, nonclinical, and CMC development plans.
Provide regulatory input into development plans to support preclinical programs and early clinical development, with strategies informed and refined through ongoing execution.
Health Authority Engagement
Serve as the primary regulatory point of contact with FDA and other global health authorities (e.g., MHRA, EMA).
Lead strategic planning and preparation for regulatory interactions, including early advice engagements, platform discussions, informal and formal agency meetings.
Develop regulatory questions, meeting objectives, and overall regulatory positioning to guide health authority engagement and inform development decisions.
Lead the development of health authority briefing packages by establishing the regulatory framework, key messages, and data narrative, and contributing to authoring in collaboration with subject matter experts and medical writers.
Document, interpret, and integrate health authority feedback into regulatory and development strategy, and coordinate responses to health authority requests
Regulatory Designations & Applications
Author and lead preparation of regulatory designation applications, such as Orphan Drug, Rare Pediatric Disease, Fast Track, and other applicable expedited programs.
Develop supporting regulatory rationale and cross functional data narratives to support designation requests.
Manage submission, agency correspondence, and follow up related to regulatory designations.
Regulatory Submissions & Lifecycle Management
Lead cross‑functional planning of regulatory submissions and amendments, including IND submissions to FDA, and provide regulatory oversight of CRO‑led regulatory activities and submissions outside the United States.
Ensure regulatory alignment across clinical, nonclinical, and CMC components of submissions.
Lead cross‑functional planning and alignment for ongoing lifecycle management activities, including annual reports and DSURs, leveraging CRO partners for execution.
Provide regulatory review and oversight of deliverables prepared by CROs and external vendors to ensure quality, consistency, and compliance.
Cross Functional & External Collaboration
Provide regulatory guidance to leadership to inform development and regulatory decision making.
Collaborate with external regulatory consultants as strategic advisors to support regulatory positioning and health authority interactions.
Oversee and coordinate medical writing support and submission vendors for regulatory documents.
Ensure alignment between internal teams and external partners to support submission timelines.
What you've done.
Bachelor’s degree in life sciences or related discipline required; advanced degree preferred.
Minimum of 10 years of experience in biotechnology or pharmaceutical development, including Regulatory Affairs experience.
Demonstrated experience leading or supporting regulatory strategy, submissions, and health authority interactions for preclinical and/or early clinical development programs.
Experience leading FDA interactions and/or IND submissions preferred
Experience with biologics, gene therapy, or gene-editing products preferred.
Strong written and verbal communication skills, with the ability to synthesize complex scientific data into clear regulatory narratives.
Ability to operate effectively and independently in a fast-paced, early-stage development environment.
What you'll get.
The anticipated salary range for candidates for this role will be $215,000 - $235,000. The final salary offered will depend on several factors. Every employee is eligible for a bonus and new hire equity. We pay about 90% of medical, dental, and vision premiums and fund the full deductible on our HSA plan. You'll also get 12 weeks of parental leave at full pay, paid parking or transit, a 401(k) match, and discretionary time off.
Arbor is an equal opportunity employer. We're committed to a hiring process and a workplace free of bias and discrimination, and we welcome candidates of every background.