Be a key member of the Regulatory Submissions team with a growing biopharma with an expanding commercial pipeline where you can advance your career.
Title: Regulatory Submission Specialist
Location: Remote, US eastern or central time zone
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
We work with a range of life sciences organizations across multiple industry disciplines, with one of our strongest portfolio’s in Clinical Operations. With US offices strategically located on the east coast (DC Metro) and west coast (San Diego) we connect rare life sciences talent with emerging companies nationwide.
Position Overview: Regulatory Admissions Specialist
As a Regulatory Admissions Specialist, you will be reporting to a direct line manager located at the company’s headquarters. This role will be responsible for FDA submissions, maintenance activities using eCTD format, and managing eCTD submissions through ESG.
- Conduct quality control manually as well as using validation software in accordance with FDA standards
- Provide EDMS support for team members
- Author, review, and maintain Quality System documents
- Provide training on publishing processes and requirements in relation to electronic submissions
- Be a resource for new/updated regulatory procedural guidelines regarding electronic submissions
Position Requirements: Bachelor’s degree required
- 2+ years of US regulatory experience with eCTD format to FDA
- Experience with docuBridge and VEEVA Vault RIM
- Knowledge of XML
- Knowledge of ISIToolbox
- Experience working effectively in a global, matrix environment
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.