Regulatory Operations Coordinator Manager
Overview
Lead regulatory operations for n-Lorem Foundation in the U.S. while supporting preclinical and clinical development teams. Seek a professional with strong attention to detail who thrives in fast-paced biotech environments. This role drives efficiency across regulatory submissions and collaborates with cross-functional teams.
What You'll Do11
- 1Collaborate with cross functional teams to develop timelines for submissions to regulatory authorities
- 2Support authoring of regulatory communications including meeting requests and briefing packages
- 3Track regulatory milestones such as submissions holds and annual reports
- 4Maintain and file all regulatory documentation
- 5Gather stakeholder input to respond to agency inquiries promptly
- 6Prepare IND annual reports
- 7Coordinate site IRB review and approval with Clinical Development
- 8Prepare clinicaltrials.gov listings and provide annual updates
- 9Support global expansion efforts
- 10Provide reviews of data for regulatory submissions to ensure scientific rigor
- 11Develop templates for protocols cover letters and internal procedures
Requirements10
- 1U.S. work authorization
- 2BSc or MS degree in scientific discipline
- 3Minimum 3 years experience in pharma biotechnology or clinical research
- 4Working knowledge of FDA regulations relevant to clinical-stage drug development
- 5Strong attention to detail and ability to maintain accuracy in fast-paced environment
- 6Demonstrated collaboration across cross-functional teams
- 7Proven organizational and project management skills
- 8Self-motivated proactive hands-on approach with ownership
- 9Experience with regulatory document preparation and submission processes
- 10Travel up to 10% of time
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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