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Regulatory Affairs Officer - New York, United States - Brio Group
Description
Job Title:
Regulatory Affairs Officer
Company:
Biopharma Organization
Location:
Hybrid, RTP Area
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 and technologies.
Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
Position Overview:
As a Regulatory Officer, you will be responsible for liaising with project teams, preparing regulatory submissions, tracking project documentation, acting as the contact for regulatory matters, and assisting with client presentations on regulatory aspects.
Opportunity Highlights:
Serve as contact person for regulatory issues and assist with client presentations
Maintain regulatory database and review INDs
Track regulatory documentation flow and progress
Prepare regulatory and ethics dossier submissions
Procure documents for regulatory and ethics submissions, including import/export licenses
Preferred Qualifications:
Bachelor's Degree Required
3+ years of experience in Regulatory Affairs submissions
Strong expertise in IND lifecycle management and submissions
Skilled in Regulatory Publishing, eCTD, and interacting with regulatory authorities
Proficient in MS Office, detail-oriented, collaborative, and strong communication skills
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.