Regulatory Affairs Specialist

Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The opportunity 

You will provide support across all of Regulatory including Operations, Strategy and CMC. This role will provide project management of multiple Regulatory workstreams. This role will also act as a liaison between Regulatory and Clinical for support of all programs.

• Coordinate and prepare regulatory submissions in collaboration with regulatory lead(s)
• Provide and maintain IND/CTA documentation support and manage timelines for submissions
• Work with other departments and communicate when documents are needed for regulatory submission
• Provide primary authorship to routine regulatory correspondence (e.g. Annual updates)
• Supports regulatory departmental activities as needed, including the authoring and reviewing of regulatory SOPs, work instructions, and templates
• Interact with colleagues in other departments, R&D functions and Regulatory Affairs functions to deliver high quality dossiers and documents in accordance with business priorities
• Working closely with regulatory leads or regional experts (EU, Japan), assist with implementation and management of ex-US activities and dossiers
• Author documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
• Assist with archiving of documents within the Veeva document management system
• Stay abreast of regulatory guidance and changes in regulatory climate
• Provide additional support as needed for team communications on planning and logistics for health authority meetings and preparation of minutes

• Bachelor’s degree in a relevant scientific discipline
• 3-5 years experience in RA; relevant industry experience may be considered
• RAPS certificate and experience with ISI ToolBox, Starting Point templates, and Veeva Vault a plus
• Ability to work independently with minimal supervision on multiple projects simultaneously
• Understanding of drug development and regulatory requirements (standards, quality, timeliness)
• Organizational and planning ability
• Strong attention to detail and quality
• Good interpersonal and communication skills
• Ability to manage and prioritize a variety of project tasks
• Experience working with interdepartmental project teams

Why Should You Apply?

By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.

We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!

In addition, professional development is important to us.  By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.