Abeona Therapeutics Inc.(NASDAQ: ABEO) is a clinical-stage biopharmaceutical company focused on developing novel therapies for life-threatening rare genetic diseases. Developing therapies for rare disease requires new approaches and strong collaboration between researchers, industry, regulators and patient groups. Abeona was forged from the companys close collaborations with key stakeholders all dedicated to transforming new biotechnology insights into breakthrough treatments for rare diseases.
We believe emerging insights in genetics and advances inbiotechnology, as well as new approaches and collaboration between researchers, industry, regulators and patient groups, provide significant opportunities to develop breakthrough treatments for rare diseases.
The Regulatory Affairs Associate will report directly to the Vice President, Regulatory Affairsand will primarily be responsible for assisting in preparing and coordinating the submission of regulatory filings worldwide. This includes FDA INDs and IND amendments, annual reports, etc. for multiple international programs.
- Coordinate and assist in the preparation of technical documentation for use in regulatory submissions worldwide.
- Gather necessary paperwork and documentation for regulatory filings. Documentation that accompanies regulatory submissions must be complete and up-to-date. Consult with scientists and others to gather data and build a strong application for US and International submissions.
- Complete and file regulatory submission forms and necessary accompanying documentation. For example, FDA's IND, Annual Reports and IND amendments.
- File submission renewals as needed.
- Keep track of the progress of regulatory submissions, if necessary, once they're submitted to the regulatory agency.
- Communicate with the regulatory agency as required to expedite the process.
- Attend continuing education courses as often as necessary to keep current on changing Regulatory Affairs policies and procedures. Subjects covered in these courses to include pharmaceutical industry regulation and compliance, quality in pharmaceutical manufacturing, and validation and regulatory affairs in pharmaceutical manufacturing.
- Act as liaison to CRO.
- Work with CRO to file initial CTAs (clinical trial applications) and amendments.
- Track CTA filings and approvals.
- Bachelors degree (or non-US equivalent); concentration in life sciences, technical/engineering, or related field preferred.
- Experience in preparing Regulatory submissions preferred.
- An understanding of Clinical Operations and drug development is required.
- Experience in Clinical Operations or related area will also be considered.
- Concise writing, especially technical writing for regulatory and peer-reviewed submissions
- Strong communication, and interpersonal skills.
- Precise attention to detail.
- Strong problem-solving and analytical skills.
- Ability to work with rapid changes; flexible and able to balance competing priorities
- Ability to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products specific to functional work team.
- Self-motivated and capable of working in a diverse, fast-paced and dynamic environment.
- Ability to build strong relationships; communicate effectively at all levels.
- Basic computer skills, including Microsoft Office Suite.
How To Apply:
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