What are the responsibilities and job description for the Regulatory Affairs Specialist - Genomics Expert position at Integrated DNA Technologies (IDT)?
Integrated DNA Technologies (IDT) is a leader in custom oligonucleotides and innovative technologies for cutting-edge genomics applications. Our team thrives on complex challenges, collaborating to drive informed decisions with high-quality data.
We celebrate individuality, fostering an inclusive environment where our diverse team members are motivated and empowered to achieve their full potential as part of a unified global team.
This role is part of the Regulatory Affairs and Quality Assurance group located in Coralville, IA, and will be an on-site position. We engage in healthy debate, embracing our differences to accomplish great things together.
Main Responsibilities:
- Support worldwide submission activities, maintenance of approvals, and global regulatory strategies across multiple sites, ensuring compliance with 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.
- Interpret regulations, guidelines, and 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.
- Cross-functionally provide regulatory expertise, training, and process improvements, acting as a core team member on new product development teams.
Required Skills and Qualifications:
- 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.
- Familiarity with FDA, EMA, MHRA, and HC regulations, quality standards, and product development processes such as ISO 9001, US FDA 21 Part 210, 211, and 600, ICH, USP, and EP standards.
Desirable Experience:
- Previous experience with eCTD publishing software.
We offer a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees.
