This innovative biotech company is developing gene therapies for the treatment of severe neurological diseases. They are seeking a Regulatory Affairs Manager to lead the preparation and review of original INDs for their ALS and Huntington’s Disease programs. You will serve as the right hand to the SVP of Regulatory, working closely with cross-functional project teams and interacting directly with the FDA. Our client offers outstanding employee benefits including free parking and unlimited vacation time! This is an exciting opportunity to work on cutting-edge gene therapy programs and improve the lives of patients around the world.
- Contribute to and execute upon regulatory strategies for two rare disease gene therapy programs.
- Manage the planning, preparation, review of regulatory submissions (including original INDs, CTAs and future BLAs) and ensure timelines are met.
- Prepare FDA meeting requests, briefing books, and meeting preparation; respond to queries from health authorities.
- Advise on regulatory requirements during all stages of the development process.
- Proactively assess submissions for GAP analysis and creates a summary report for potential deficiencies.
- Collaborate with Subject Matter Experts to ensure delivery of high quality documentation to meet global regulatory expectations.
- Work closely with electronic publishing contractors to ensure regulatory submissions are formatted, published, and filed in a timely fashion.
- Own full responsibility for submission of documents to ClinTrials.gov and ensure all queries are addressed and data entered as required in the timeframes specified.
- Assist with development of the Target Product Profile with supporting documentation and labeling documents, including preparing package inserts, as well as aiding in quality control of labeling submissions as needed.
- Represent Regulatory Affairs as required across the company or with external partnerships as directed.
- Maintain a high level of understanding of current global regulatory requirements.
- Assist in the development, establishment and maintenance of Regulatory Affairs Policies, Operating Procedures and processes.
- Bachelor’s degree in a scientific discipline. M.S. or higher degree a plus.
- 5+ years direct regulatory affairs experience with novel development programs in the Biotech/BioPharma industry.
- Direct experience with the preparation and review of INDs and/or CTAs.
- Ability and experience in using eCTD format and templates for eCTD publishing.
- Experience working with biologics desired but not required.
- Strong knowledge of GCP, GLP and GMP regulations and other guidelines.
- Experience preparing meeting requests and briefing books. Coordinating and responding to Health Authority questions is a plus.
- Excellent communication skills and ability to effectively work in a team environment while developing peer relationships.
- Must be highly organized and have the ability to meet critical deadlines.
- Ability to work independently and proactively in a fast-paced environment.