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Company | Talentify.io |
Address | United States |
Employment type | FULL_TIME |
Salary | |
Category | Administrative and Support Services |
Expires | 2023-09-13 |
Posted at | 9 months ago |
San Francisco, CA /
- Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with global requirements
- Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
- Serve as key regulatory team member with responsibility for providing strategic and operational regulatory direction and support on projects including, but not limited to, overall regulatory strategies, regulatory requirements for clinical studies, regulatory strategic development plans and risk assessments, critical issue management and leadership of health authority interactions.
- Responsible for assisting with the development and implementation of regulatory processes
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations
- Support due diligence and partnering activities, as needed
- Recruits, develops, manages, and mentors regulatory professionals and helps create a supportive and growth-minded culture
- Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
- Act as the primary liaison with regulatory authorities
- Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
- Provide regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development
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