Job Details - Regulatory Affairs Manager - 40140550 | Frederick National Laboratory Talent Network
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Regulatory Affairs Manager II/III in Frederick, MD

Location: Frederick, MD
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Regulatory Affairs Manager II/III

Job ID: req2012
Employee Type: exempt full-time
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 Position Overview:

PROGRAM DESCRIPTION         

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Laboratory for Cancer Research (FNLCR) and other government agencies through the development of novel agents for first-in-man clinical studies.

 KEY ROLES/RESPONSIBILITIES

  • Supervises Regulatory Affairs staff and manages the preparation, review, and completion of biologic chemistry, manufacturing, and controls (CMC) sections (Modules 2 and 3) and CMC amendments of Investigational New Drug Applications (IND's) to meet established timelines
  • Review and interpretation of completed batch records, standard operating procedures, and in-process and final product quality control testing to abstract technical information required for Phase I-III IND CMC sections is necessary
  • Manages the Document Control Group that is responsible for generation, review, approval, and storage of BDP GMP documentation
  • Knowledgeable in managing the preparation of requests/briefing packages for regulatory agency meetings including FDA PreIND and INTERACT meetings
  • Supervises and prepares responses to FDA/regulatory agency questions as required
  • Responsible for supervising and approving Facilities Master File amendments and annual reports
  • Manage the preparation of Manufacturing reports for various biologic products
  • Must be able to interact with scientific staff, support staff, and customers to ensure appropriate documentation is available for CMC sections, and all required reports
  • Monitors and tracks completion of documents from other areas needed for regulatory document deadlines
  • Keeps abreast of FDA/ICH regulations and changes and provides updates to ensure compliance by BDP staff
  • Reviews, revises, and approves Standard Operating Procedures to adhere to FDA regulations and CGMP
  • Develops budgets, schedules, and performance requirements for regulatory affairs and document control groups and ensures requirements are met

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
    • Mgr II, Reg Affairs - In addition to the education requirement, a minimum of six (6) years of progressively responsible experience, including four (4) years of experience in a leadership capacity
    • Mgr III, Reg Affairs - In addition to the education requirement, a minimum of ten (10) years of progressively responsible experience, including four (8+) years of experience in a leadership capacity
  • Ability to obtain and maintain a security clearance

PERFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Biologics/pharmaceutical related research, manufacturing, and product development experience
  • Regulatory Manager experience, and GMP Document Control experience
  • Gene therapy, cell therapy, monoclonal antibody, recombinant proteins, and/or viral vaccine development experience
  • Omnicia Software and Master Control Software experience
  • Supervisory experience

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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