Job Description

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team.

IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position is part of the Regulatory Affairs and Quality Assurance group located in Coralville, IA and will be an on-site position. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things.

In this role, you will have the opportunity to:

• Support a team responsible for worldwide submission activities, maintenance of approvals and global regulatory strategies, across multiple sites, in support of DMF, Annual Reports, Supplements, Pre-IND and IND submissions, annual renewals, change notifications, post-market surveillance activities, etc. Provide guidance, mentoring, and support to regulatory colleagues with less experience.
• Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity.
• Author and/or review regulatory documents for domestic and global market entry to achieve departmental and business objectives.
• Work cross-functionally to provide regulatory expertise, training, and process improvements, and act as core team member on new product development teams.

The essential requirements of the job include:

• 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 the FDA, EMA, MHRA and HC regulations, quality standards and product development process such as ISO 9001, US FDA 21 Part 210, 211 and 600, ICH, USP and EP standards.

It would be a plus if you also possess previous experience in:

• Experience in eCTD publishing software.

You should be proficient in:

• Quality Inspection Experience
• Bachelor's Degree
• FDA Regulations

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