Manager, Regulatory Affairs

Join us as a Manager, Regulatory Affairs!

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.

Abeona Therapeutics Inc.: Who We Are

Our Values: Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Your day-to-day as a Manager, Regulatory Affairs

The Manager, Regulatory Affairs will support regulatory strategy and execution for investigational and commercial cell and gene therapy programs. This individual will contribute to the preparation, submission, and lifecycle management of IND and BLA filings, with particular emphasis on CMC regulatory activities and health authority interactions. The role requires a hands-on contributor who can manage multiple priorities, collaborate effectively across functions, and operate successfully in a fast-paced, resource-efficient small biotech environment.

Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

Schedule

The usual working hours for this role are Monday to Friday during normal business hours (with some late night or weekend work on occasion).

Does this sound like you?

To thrive as a Manager, Regulatory Affairs, the right combination of experience, education, skills, and attitude is essential.

Are you someone with strong organizational skills and experience with reviewing, authoring, and submitting technical content for regulatory submissions? Are you able to work cross-functionally across a spectrum of stakeholders to ensure that submissions, reports, and data packages are in line with authority expectations? Do you have a strong working knowledge of regulatory guidelines including 21 CFR Parts 210, 211, 312, 600, and 601? Are you mission driven, and inspired by playing a part in changing patient lives?

Essential Responsibilities and Duties

Health Authority Filings

• 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

CMC Regulatory

• 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

FDA Meetings & Agency Interactions

• 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

Gene Therapy/ATMP Regulatory Strategy

• 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

Required Qualifications

The knowledge and skills required to be successful in the role are:

• 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

Preferred Qualifications

• Experience and prior work in a startup or small company environment where multiple programs and priorities are managed concurrently

Competencies & Attributes

• 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

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is 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 work in laboratory, cleanroom, or manufacturing environments may be required. Occasional lifting up to 25 pounds is 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. Must be able to travel between company sites or to vendor locations, if needed.

Important Notes for Candidates:

Visa Sponsorship Not Currently Available

• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
• This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• Current or future H-1B sponsorship is not available for this role.

Additional Notes to Applicants:

• Due to the volume of applications received, we are unable to respond to every applicant. Only candidates whose qualifications most closely match the requirements of the position and who successfully complete the initial stages of the selection process will be contacted.
• All applications will be reviewed in accordance with applicable federal, state, and local employment laws.

EEOC Disclaimer

We're committed to building a workplace where everyone feels welcome. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, age, disability, veteran status, or any other protected status.

Connect with our team today!

If you're ready to take your career to the next level and join a team that values hard work and changing lives - complete our application today!