REGENXBIO Inc.
Regulatory Affairs Specialist
REGENXBIO Inc., Rockville, Maryland, us, 20849
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.
What you'll be doingCoordinate and prepare regulatory submissions in collaboration with regulatory lead(s)Provide and maintain IND/CTA documentation support and manage timelines for submissionsWork with other departments and communicate when documents are needed for regulatory submissionProvide 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 templatesInteract with colleagues in other departments, R&D functions and Regulatory Affairs functions to deliver high quality dossiers and documents in accordance with business prioritiesWorking closely with regulatory leads or regional experts (EU, Japan), assist with implementation and management of ex-US activities and dossiersAuthor 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 systemStay abreast of regulatory guidance and changes in regulatory climateProvide additional support as needed for team communications on planning and logistics for health authority meetings and preparation of minutesWe set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
Bachelor's degree in a relevant scientific discipline3-5 years experience in RA; relevant industry experience may be consideredRAPS certificate and experience with ISI ToolBox, Starting Point templates, and Veeva Vault a plusAbility to work independently with minimal supervision on multiple projects simultaneouslyUnderstanding of drug development and regulatory requirements (standards, quality, timeliness)Organizational and planning abilityStrong attention to detail and qualityGood interpersonal and communication skillsAbility to manage and prioritize a variety of project tasksExperience 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.
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.
What you'll be doingCoordinate and prepare regulatory submissions in collaboration with regulatory lead(s)Provide and maintain IND/CTA documentation support and manage timelines for submissionsWork with other departments and communicate when documents are needed for regulatory submissionProvide 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 templatesInteract with colleagues in other departments, R&D functions and Regulatory Affairs functions to deliver high quality dossiers and documents in accordance with business prioritiesWorking closely with regulatory leads or regional experts (EU, Japan), assist with implementation and management of ex-US activities and dossiersAuthor 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 systemStay abreast of regulatory guidance and changes in regulatory climateProvide additional support as needed for team communications on planning and logistics for health authority meetings and preparation of minutesWe set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:
Bachelor's degree in a relevant scientific discipline3-5 years experience in RA; relevant industry experience may be consideredRAPS certificate and experience with ISI ToolBox, Starting Point templates, and Veeva Vault a plusAbility to work independently with minimal supervision on multiple projects simultaneouslyUnderstanding of drug development and regulatory requirements (standards, quality, timeliness)Organizational and planning abilityStrong attention to detail and qualityGood interpersonal and communication skillsAbility to manage and prioritize a variety of project tasksExperience 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.