The Sr. Regulatory Affairs Specialist will be responsible for supporting the organization’s ongoing FDA (IVD, Biologics, Antibodies) and IVDR projects. The role will support high quality submissions including EUAs, 510ks, Technical Documentation for EU, and amendments. Additional responsibilities also include publishing and archiving regulatory submissions.
What You’ll Be Doing
- Edit, review, and quality control the scientific/technical contents of nonclinical reports and sections of EUA/IVDR/510k to be submitted to health authorities.
- Perform routine general formatting, template adherence, version control and routine document processing activities associated with the preparation of submission-standard regulatory documents for electronic submissions
- Participate in the electronic compilation and publishing of routing documents and reports using eCTD publishing tools
- Be able to identify basic issues
- Utilize systems and tools for electronic document capture, generation, manipulation, scanning, and QC
- Ensure final document components are electronically archived
- May interface with cross-functional teams and or content authors to discuss routine submission preparation and content
What You’ll Bring to the Team
- Bachelor's degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
- 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations or related area.
- 3-4 years/ experience in regulated industry (e.g. pharmaceuticals, biologics, medical products, IVD)
- High degree of focus and strong attention to detail
- Excellent organizational, analytical, and technical skills
- Must be flexible, able to handle multiple projects simultaneously, and work efficiently to be able to satisfy specific timelines and deliverables
- Solid understanding of ISO 14971, ISO 13485, 21 CFR 820, 21 CFR 210/211, ICH
- Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required
- Experience with document management systems required
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Experience with Atlassian Confluence and JIRA.
- Experience with regulatory submissions for next generation of antibody-drug conjugates (ADCs) and In Vitro Diagnostic products.
- Experience designing and executing studies for FDA submissions and/or responses to FDA
About Twist Bioscience
Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.
At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.
Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.