What are the responsibilities and job description for the Senior Regulatory Compliance Manager position at Integrated DNA Technologies (IDT)?
At IDT, we're pushing the boundaries of genomics applications, and our Regulatory Affairs and Quality Assurance team is critical to this success. As a Senior Regulatory Affairs Specialist, you'll play a key role in supporting worldwide submission activities, ensuring compliance with regulatory requirements, and providing guidance to colleagues.
We're looking for a talented individual with a strong background in global regulatory affairs, preferably with experience in the pharmaceutical industry. Your expertise will help us maintain approvals and develop strategic plans for regulatory submissions.
This role offers an exciting opportunity to work cross-functionally with various teams, including research and development, marketing, and sales. 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.
Key Responsibilities:
- 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.
- Develop and implement effective regulatory strategies to meet business objectives.
What We Offer:
- A dynamic work environment that fosters collaboration and innovation.
- Ongoing professional development opportunities to enhance your skills and knowledge.
- A comprehensive benefits package, including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees.
