Senior Regulatory Affairs Associate - Center for Gene Therapy (90002114)

Baylor College of Medicine

Houston, TX

Job posting number: #7069533 (Ref:4717-en_US)

Posted: September 4, 2020

Application Deadline: Open Until Filled

Job Description

Job Purpose

Senior Regulatory Affairs Associate is responsible for coordinating the regulatory and administrative requirements for conducting research; provides guidance in the accumulation of regulatory documentation.

Job Duties
  • Applies a detailed understanding of federal and international regulatory requirements when preparing regulatory review applications.
  • Assists and advises Investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
  • Conducts regulatory affairs training.
  • Supports study monitoring as needed.
  • Communicates with IRBs and PIs related to submissions, renewals, and adverse events.
  • Develops, implements, and maintains appropriate policies, procedures, and standards concerning projects.
  • Serves as main contact for investigators, sponsors, government agencies, and the IRB.
  • Performs other job-related duties as assigned.
Minimum Qualifications
  • Education Required: Bachelor's degree.
  • Experience Required: Four years of relevant experience.
  • Certification/Licenses/Registration: None Required.
Preferred Qualifications
  • Regulatory knowledge and communication skills to help prepare a new IND submission to the FDA.





Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.



Baylor College of Medicine fosters diversity among its students, trainees, faculty and staff as a prerequisite to accomplishing our institutional mission, and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. - Diversity, respect, and inclusiveness create an environment that is conducive to academic excellence, and strengthens our institution by increasing talent, encouraging creativity, and ensuring a broader perspective. - Diversity helps position Baylor to reduce disparities in health and healthcare access and to better address the needs of the community we serve. - Baylor is committed to recruiting and retaining outstanding students, trainees, faculty and staff from diverse backgrounds by providing a welcoming, supportive learning environment for all members of the Baylor community.

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More Info

Job posting number:#7069533 (Ref:4717-en_US)
Application Deadline:Open Until Filled
Employer Location:Baylor College of Medicine
United States
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