Sr. Clinical Research Regulatory Specialist - Chemistry, Manufacturing, and Controls (CMC)

Job Responsibilities

• Develop and revise compliance programs, policies, and procedures related to human research protections, research review processes, Investigational New Drug (IND), Investigational Device Exemption (IDE) proposals, and investigational products under the purview of the FDA, RAC, and OBA.
• Liaise with external entities including government regulatory authorities and agencies, and coordinate audits and site visits for external regulatory agencies.
• Act as a project leader for assigned projects related to regulatory submissions, and assist in the drafting, assembly, review, and revision of IND/IDEs and other regulatory applications for review committees (e.g., CT-SRC, IRB, IMC, DSMB, etc.).
• Resolve issues/inquiries/deficiency letters with regulatory and follow up to ensure initial applications are approvable.
• Assist with the administration of the regulatory research compliance plan.
• Identify risk areas and assist in developing quality assurance auditing, monitoring, and oversight processes in line with regulatory requirements and institutional policies.
• Provide ongoing feedback to clinical research investigators and teams to support compliance.
• Assist with the planning, development, and implementation of training and education programs related to regulatory/ compliance/quality assurance.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Minimum Education and/or Training

• Bachelor's degree in relevant area required.

Minimum Required Experience

• 4+ years of experience in related field (e.g., quality, regulatory affairs, human research protection program compliance, or policymaking in government or pharma industry)
• Proven performance in earlier role.

Preferred Experience

• Chemistry, Manufacturing, and Controls (CMC) writing experience
• Experience/ knowledge of IND (Investigational New Drug) and NDA (New Drug Application)
• Professional affiliation with one of more of the following: American Society of Gene & Cell Therapy (ASGCT), International Society for Cell & Gene Therapy (ISCGT), Regulatory Affairs Professionals Society (RAPS)

Licensure, Registration and/or Certification Required and/or Preferred by SJCRH Only:

• Applicable certification preferred (e.g., Society of Clinical Research Associates (SoCRA), Association of Clinical Research Professionals (ACRP), Certified IRB Professional (CIP), Regulatory Affairs Certification (RAC), Certified Healthcare Research Compliance (CHRC))

Compensation

In recognition of certain U.S. state and municipal pay transparency laws, St. Jude is including a reasonable estimate of the compensation range for this role.

This is an estimate offered in good faith and a specific salary offer takes into account factors that are considered in making compensation decisions including but not limited to skill sets, experience and training, licensure and certifications, and other business and organizational needs.

It is not typical for an individual to be hired at or near the top of the salary range and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current salary range is $78,000 - $139,360 per year for the role of Sr. Clinical Research Regulatory Specialist - Chemistry, Manufacturing, and Controls (CMC).

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