Manager, Regulatory Affairs

Abeona Therapeutics Inc.•,

1d•$100,000 - $120,000•Remote

About The Position

Join Abeona Therapeutics as a Manager, Regulatory Affairs and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards. Collaborate with talented individuals dedicated to transforming lives through innovative therapies. This is a remote position working Monday to Friday during daily business hours (some late or weekend work may be required) that plays a significant role in contributing to impactful products that change people's lives. With a competitive salary of $100,000 to $120,000 per year (plus annual discretionary bonus and equity opportunities), this position not only offers financial rewards, but also the opportunity to build your career in a supportive, collaborative, and values-focused environment. You will have options to participate in a comprehensive benefits program that includes options for Medical insurance to meet various individual/family needs, company covered basic Dental and Vision insurance (with additional coverage options), HSA and FSA options, a Lifestyle Spending Account, 401k options (with a company match program), and up to 160 hours of Paid Time Off per calendar year.

Requirements

Bachelor's degree in biology, biochemistry, pharmacy, chemistry, engineering, or a related life science discipline; an advanced degree preferred
3-5 years of regulatory affairs experience in the biopharmaceutical industry, with direct experience supporting development-stage programs
Demonstrated experience in responding to health authority information requests
Working knowledge of manufacturing processes, analytical development, specifications, stability, or comparability
Experience supporting FDA interactions, including meeting packages, meeting preparation, or written responses to agency questions
Familiar with applicable FDA regulations, including 21 CFR Parts 210, 211, 312, 600, and 601, and relevant CBER guidance documents
Exposure to regulatory document management, publishing, submission tracking, or commitment management systems
Strong analytical and strategic thinking skills, with excellent attention to detail and scientific judgment
Clear written and verbal communication skills, with the ability to translate complex regulatory and scientific information for cross-functional audiences
Proactive, practical, and solutions-oriented approach; comfortable working through ambiguity and changing priorities
Collaborative team member who can influence cross-functional partners and build effective working relationships
High degree of accountability and ownership, with the ability to manage assigned timelines, deliverables, and priorities independently
Regularly required to experience prolonged sitting, some bending, stooping, and stretching.
Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
A normal range of hearing and vision correctable to 20/20 is required.
Occasional lifting up to 25 pounds is required.
Must be able to travel between company sites or to vendor locations, if needed.

Nice To Haves

Experience and prior work in a startup or small company environment where multiple programs and priorities are managed concurrently
Occasional work in laboratory, cleanroom, or manufacturing environments may be required.
May require wearing appropriate personal protective equipment (PPE) when entering GMP or lab areas.
Occasional walking, standing, or climbing stairs within office or facility settings.

Responsibilities

Coordinate the preparation, authoring, review, and submission of technical content for INDs, IND amendments, BLAs, and related regulatory filings in eCTD format
Manage assigned submission timelines and collaborate with CMC, Clinical, Nonclinical, Quality, and Regulatory Operations partners to support timely, high-quality filings
Author, compile, and review assigned Module 1, 2, and 3 content for accuracy, consistency, and completeness
Maintain submission trackers, regulatory calendars, correspondence logs, and agency commitment records
Support preparation of annual reports, safety reports, development safety update reports, and post-submission amendments, as applicable
Support development and implementation of CMC regulatory strategies for cell and gene therapy IND and BLA programs, and critical starting materials such as viral vectors, cell banks, and plasmid DNA
Author and review CMC submission content, including manufacturing process descriptions, analytical methods, specifications, stability data, comparability assessments, and control strategy justifications
Assess CMC changes and support preparation of appropriate regulatory filings, including annual reportable changes, CBE-0, CBE-30, and Prior Approval Supplements, as applicable
Partner with process development, analytical development, manufacturing, Quality, and supply chain teams to ensure CMC data packages are scientifically sound and aligned with health authority expectations
Provide regulatory input to technology transfer, scale-up, process validation, and CMO/CDMO oversight activities
Support compliance with applicable regulations and guidance, including 21 CFR Parts 210, 211, 312, 600, and 601; relevant FDA guidance for human cell and gene therapy products; and ICH Q8, Q9, Q10, Q11, and Q12
Contribute to preparation of Type A, Type B, Type C, and Type D meeting requests, briefing packages, meeting materials, and responses to FDA questions
Participate in FDA and other health authority meetings, as needed, and support development of meeting minutes and follow-up actions
Support clear, timely, and accurate communications with FDA reviewers within CBER and the Office of Therapeutic Products
Track and coordinate completion of agency commitments arising from meetings, information requests, and formal correspondence
Monitor relevant FDA guidance, policy updates, and PDUFA-related developments and communicate potential impacts to internal stakeholders
Apply working knowledge of U.S. and global advanced therapy regulatory frameworks to support development strategies for viral vector-based and cell-based programs, including AAV, lentiviral, CAR-T, and hematopoietic stem cell therapies
Support regulatory pathway and designation assessments, including Accelerated Approval, Breakthrough Therapy, RMAT, Fast Track, etc.
Contribute to global regulatory strategies and submission planning, including interactions with EMA and other health authorities, as applicable
Provide regulatory input on manufacturing comparability, lot release testing, potency strategy, long-term follow-up, and clinical hold risk mitigation for cell and gene therapy products
Coordinate activities with external regulatory consultants, contract research organizations, vendors, and industry working groups, as assigned