Summary

The Regulatory Affairs Manager 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 Regulatory Affairs Manager works closely with the Director to oversee all aspects of clinical research within CAGT.  The job is both fast paced and high profile requiring significant ability to concentrate, understand complex scientific concepts and juggle multiple priorities. The ideal candidate will be highly organized, intelligent and motivated. Strong problem-solving skills are required. 

The position is eligible for a hybrid work schedule.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) are eligible for certification pay.

Job Duties

• 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.
• Responsible for confirming the content of regulatory submissions.
• Work 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. As necessary submits and maintains such documents.
• Assist and prepare for FDA meetings, inspections, and audits from regulatory agencies.
• Help to maintain systems meant to optimize communication of changes in regulatory processes to investigators, regulatory staff, and other involved parties.
• Help to maintain systems meant to optimize protocol specific information distribution to investigators, research staff, and other health care providers.
• Assist in submission and maintenance of regulatory documents as needed to ensure that all clinical research projects remain open and are conducted in compliance with all regulations and policies (federal and local).
• Supervise a team of regulatory professionals.
• Perform other duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience. 

Preferred Qualifications

• Master's degree
• Five years in regulatory affairs/compliance
• Experience working with the FDA
• Oncology/Cell and Gene therapy experience
• Project Management experience
• Strong computer skills and excellent organizational skills