• Charleston, SC, USA
  • Full Time

The regulatory manager (RM) manages regulatory staff and regulatory staff project assignments. The RM manages resources to meet internal and external GCP compliance audit programs in conjunction with clinical operations. RM manages the regulatory leads and regulatory associates and guides the accumulation of regulatory documentation and prepares and/or reviews submissions for therapeutic, medical, or diagnostic device licenses to local or central IRBs. The RM collects regulatory documents in an ongoing manner to maintain compliance with FDA, ICH, HIPAA, local, state or country laws and regulations. RA reviews, corrects with site, tracks activity and forwards regulatory documents to the sponsor. The RA interfaces with individual study sites to assure compliance with Good Clinical Practices (GCP), FDA and ICH and serves as an advisor on compliance difficulties. Participate in mentoring site and internal CRO staff regarding protocol and compliance issues and/or regulatory process and QC best practices. Maintain awareness of all FDA/GCP and ICH changes in regulations and forms. Interface with IRB/EC, Sponsor, Study Coordinators, and Investigators to assure that compliance measures happen in accordance with regulations and in a timely manner. Bring regulatory concerns to the attention of the Clinical Operations Manager/Director or Sr. Director and participate in intervention needs, plan and implementation and measurement of intervention success.

Primary Responsibilities

  • Assigns responsibility of regulatory duties to regulatory assistant manager or associates as required for each trial or TMF/eTMF migration effort and maintenance of NCGS SOPs and GCP compliance standards
  • Acts as regulatory liaison between clinical operations, medical/safety and sponsor groups to meet regulatory compliance standards.
  • Reviews regulatory publications and government postings to keep apprised of new regulatory guidance. Communicates these new guidances to applicable departments and initiates changes to SOPs as required.
  • Attends manager meetings
  • Prepares and conducts presentations for sponsor specific meetings
  • Reviews and develops informed consent templates as required
  • Investigates qualifications of any IRB utilized
  • Confirms investigational sites/principal investigators, are not listed on the FDA blacklist
  • Attends or delegates attendance to PI/Sponsor meetings.
  • Works in partnership with clinical operations and any quality assurance initiatives in designing and enhancing quality management systems to facilitate overall Regulatory compliance.
  • Establishes and maintains policies and procedures to ensure compliance with government regulations and Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines.
  • Responsible for database tracking of study sites; Regulatory documents and status from site recruitment/ targeting to study close, including database design and management, query and report design.
  • Responsible for the distribution of Regulatory documents to the sites, including materials needed for IRB submission/approval, site activation, drug shipment, study completion, Investigational New Drug (IND) safety reports, Regulatory correspondence, correspondence from the Sponsor, protocol(s)/ amendments and Regulatory binders in accordance with the Code of Federal Regulations (CFR), NCGS Standard Operating Procedures (SOPs) and Sponsor guidelines.
  • Responsible for final review of Regulatory documents to ensure compliance with FDA, Sponsor, and NCGS SOPs.
  • Responsible for tracking study site's IRB submission sites, IRB meeting dates, IRB approval status, IRB approval of protocols, Informed Consents, investigator brochures and IRB approval letter expiration dates.
  • Responsible for submission of Regulatory documents to Sponsor before activation, during the study and at study closeout.
  • Responsible for the dissemination of study sites' outstanding Regulatory documents to the NCGS Clinical team for the collection, and/ or for contacting the study sites to obtain outstanding Regulatory documents.
  • Acts as Regulatory liaison for medical or clinical research groups to keep Regulatory affairs department apprised of research progress.
  • Reviews Regulatory publications to keep apprised of new Regulatory developments. Communicates new developments to Manager of Regulatory Compliance.
  • Assist Central Files and Project Coordinators as needed.
  • Participates in conference calls and provide necessary Regulatory updates to Sponsor.
  • Supervises regulatory staff
  • Mentors clinical operations staff regarding regulatory compliance
  • Prepares and conducts internal training

Knowledge, Skills and Abilities

  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
  • Basic understanding of mathematical concepts.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • To perform this job successfully, an individual should have knowledge of database software, spreadsheet software and word processing software.

Education and Experience

  • Bachelor Degree (BA/BS) from four-year college or university or Associate's degree (AA) or equivalent from two-year college or technical school and/ or six years related experience and/or training; or equivalent combination of education and experience and certifications.
  • 6 years or greater of industry experience with at least 2 years of general management experience and demonstrates the ability to:
    • Analyze problems to identify significant factors, gather pertinent data, and recognize solutions;
    • Plan and organize work; and
    • Communicate effectively orally and in writing.
    • Manage the work of others.
    • Mentor and evolve staff and/or enterprise wide programs.
  • Experience of a general clerical nature (typing, filing, routine procedural processing, maintaining records, or other non-specialized tasks) is not creditable.
  • Experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. To be creditable, specialized experience must have been equivalent to at least the next lower level of responsibility in the normal line of progression for the occupation in the organization or previous organization.
  • Combinations of successfully completed post-high school education and experience may be used to meet total qualification requirements. Consideration of applicant's total qualifying experience as a percentage of the experience required for the position combined with the applicant's education as a percentage of the education required for the position; and then adding the two percentages. The total percentages must equal at least 100 percent to qualify an applicant for this position.
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