What are the responsibilities and job description for the Global Regulatory Strategist - DNA Technologies position at Integrated DNA Technologies (IDT)?
As a Global Regulatory Strategist at IDT, you'll be responsible for developing and implementing regulatory strategies to support our genomics applications. This role requires a deep understanding of global regulations, quality standards, and product development processes.
You'll work closely with cross-functional teams to ensure compliance with regulatory requirements and provide guidance to colleagues. Your expertise will help us maintain approvals and develop strategic plans for regulatory submissions.
This role offers an exciting opportunity to work at the forefront of genomics applications, driving informed decisions with high-quality data. You'll have the chance to make a meaningful impact on our business while staying up-to-date with the latest regulatory developments and best practices.
Main Responsibilities:
- Develop and implement regulatory strategies to meet business objectives.
- Maintain awareness of evolving regulatory landscapes and update internal procedures accordingly.
- Support regulatory submission activities, including DMF, Annual Reports, Supplements, Pre-IND and IND submissions, annual renewals, change notifications, and post-market surveillance activities.
- Collaborate with colleagues to ensure compliance with regulations, quality standards, and product development processes.
Requirements:
- 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.
