About the Role: 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 Chief Medical Officer, 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 Can Expect: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 Bring: - 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.
The anticipated salary range for candidates for this role will be $215,000 - $235,000. 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.
