Baylor College of Medicine: Assistant Director of Regulatory Affairs

Posting Number: 257285DP

BCM Department: Center for Cell and Gene Therapy

Location: BCM Main Campus, Houston, TX

Salary Range:  Hiring up to $103,000

Employment Duration:  Full-time

The Assistant Director (AD) provides analytical, regulatory, and supervisory support for the clinical research/regulatory team at The Center for Cell and Gene Therapy (CAGT). This support includes, but is not limited to, training and supervising regulatory staff, helping investigators develop regulatory strategies, analyzing changes in regulations for impact on CAGT protocols. The AD works closely with the Director to oversee all aspects of clinical research within for CAGT.

Actively works to maintain timely knowledge of federal regulations, institutional policies and ICH GCP guidelines in order to properly guide regulatory staff and investigators in preparing projects that are in compliance with those documents.

Helps to create SOPs that guide internal processes in order to facilitate compliance with federal regulations, institutional policies and ICH GCP guidelines.

Works with the regulatory staff and investigators in developing protocol documents and consent forms as necessary, works with regulatory staff and investigators to assist in responding to queries from institutional review committees and other regulatory agencies including the FDA.

Develops and maintains positive relationships with regulatory agencies, sponsors and other sites through oral and written communications.

Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies.

Helps to maintain systems meant to optimize communication of changes in regulatory processes to investigators, regulatory staff, and other involved parties.

Helps to maintain systems meant to optimize protocol specific information distribution to investigators, research staff, and other health care providers.

Required:

Bachelor’s degree.

Three years in a regulatory affairs or compliance role.

Experience working with the FDA.

Preferred: 

Master’s degree.

Five years in a regulatory affairs or compliance role.

Oncology, Cell or Gene Therapy experience.

Project Management experience.

Skills:

Excellent communication, writing and editing skills.

Excellent organization skills.

Strong computer skills including Microsoft Office Suite and database knowledge.

The following is a list of the Required and Optional documents for this position. Please be sure to have them ready before you submit your application.

Required Documents: Resume/CV

Applicants to the position should email Bambi Grilley at bjgrille@txch.org.

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