What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at Integrated DNA Technologies (IDT)?
Integrated DNA Technologies (IDT) is a leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications.
We are complex and cutting-edge, seeking curious, creative thinkers who understand the importance of good data in driving smart decisions.
IDT is part of the Danaher Life Sciences family, accelerating discovery, development, and delivery of solutions that safeguard and improve human health.
This role is located in Coralville, IA, and will be an on-site position within our Regulatory Affairs and Quality Assurance group.
About this Role
- You will support worldwide submission activities, maintenance of approvals, and global regulatory strategies across multiple sites.
- You will interpret statutes, regulations, guidance, and quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.
- You will author and/or review regulatory documents for domestic and global market entry to achieve departmental and business objectives.
- You will work cross-functionally to provide regulatory expertise, training, and process improvements, and act as a core team member on new product development teams.
Requirements
- Minimum bachelor's degree in a technical field such as chemistry, biochemistry, biology, or related required.
- Minimum 3 years of global regulatory experience related to drug substances and/or drug products.
- Knowledge and experience of FDA, EMA, MHRA, and HC regulations, quality standards, and product development processes.
Preferred Qualifications
- Experience in eCTD publishing software.
We Offer
A comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
Danaher Corporation is committed to equal opportunity and diversity, valuing unique perspectives and differences found in our workforce, workplace, and markets we serve.
