What are the responsibilities and job description for the Life Science Program Manager position at Leidos?
Description
The Health & Civil Sector at Leidos currently has an opening for a Program Manager to work out of our Frederick, MD office. This is an exciting opportunity to use your experience to support the Division of Microbiology and Infectious Diseases (DMID) Regulatory Affairs Support Contract and others. We support DMID by developing and aligning regulatory strategy to successfully take their investigational vaccine, drug, or device product through the regulatory pipeline. Duties require strong communications skills.
Primary Responsibilities.
Manage a small staff of regulatory professionals to ensure contract deliverables are of the highest quality and submitted on time;
Participate in monthly meetings and check-in calls to provide solutions for potential inefficiencies and/or staffing responsibilities;
Prepare, author and/or review regulatory documents for Investigational New Drug applications (INDs), Investigational Device Exemptions (IDEs), Master Files (MFs), Biologics License Applications (BLAs), and New Drug Applications (NDAs);
Prepare, compile and/or publish regulatory submissions in accordance with electronic Common Technical Document (eCTD) requirements;
Collect and review study-specific documentation for protocols, update regulatory database systems, and maintain regulatory files as required;
Apply regulations and guidelines (e.g., 21 CFR, ICH, FDA guidance documents, etc.) for clinical research, regulatory compliance and quality review of submissions to the FDA;
Serve as a Regulatory Affairs Subject Matter Expert and be able to set and respond to priorities of each of the projects;
Participate in locating opportunities and writing responses to proposals to grow the regulatory department.
Basic Qualifications.
Must possess a Bachelor’s Degree in a related life science with 12 years of prior relevant experience or Master’s Degree in a life science with 10 years of relevant experience;
Must have proven track record for successfully leading and managing project teams;
Must be well-versed and affluent in Chemistry, Manufacturing, and Controls as well as 21 CFR Parts 50, 58, 211, 312, 314, Subchapter H (Medical Devices), and 45 CFR Part 46, as well as applicable FDA and ICH Guidances;
Must be able to obtain and maintain a Public Trust Security Clearance;
Must have 10 years of US FDA Regulatory Affairs experience;
Must be familiar with DocuBridge, FDA’s ESG and e-STAR programs, and validation software used for submitting regulatory documentation.
Preferred Qualifications. Regulatory Affairs Certification for US; experience with vaccine development; International Clinical trials experience; familiarity with NIH Institutes and its missions.
Original Posting
April 7, 2025
For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.
Pay Range
Pay Range $126,100.00 - $227,950.00
The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
#Remote
The Health & Civil Sector at Leidos currently has an opening for a Program Manager to work out of our Frederick, MD office. This is an exciting opportunity to use your experience to support the Division of Microbiology and Infectious Diseases (DMID) Regulatory Affairs Support Contract and others. We support DMID by developing and aligning regulatory strategy to successfully take their investigational vaccine, drug, or device product through the regulatory pipeline. Duties require strong communications skills.
Primary Responsibilities.
Manage a small staff of regulatory professionals to ensure contract deliverables are of the highest quality and submitted on time;
Participate in monthly meetings and check-in calls to provide solutions for potential inefficiencies and/or staffing responsibilities;
Prepare, author and/or review regulatory documents for Investigational New Drug applications (INDs), Investigational Device Exemptions (IDEs), Master Files (MFs), Biologics License Applications (BLAs), and New Drug Applications (NDAs);
Prepare, compile and/or publish regulatory submissions in accordance with electronic Common Technical Document (eCTD) requirements;
Collect and review study-specific documentation for protocols, update regulatory database systems, and maintain regulatory files as required;
Apply regulations and guidelines (e.g., 21 CFR, ICH, FDA guidance documents, etc.) for clinical research, regulatory compliance and quality review of submissions to the FDA;
Serve as a Regulatory Affairs Subject Matter Expert and be able to set and respond to priorities of each of the projects;
Participate in locating opportunities and writing responses to proposals to grow the regulatory department.
Basic Qualifications.
Must possess a Bachelor’s Degree in a related life science with 12 years of prior relevant experience or Master’s Degree in a life science with 10 years of relevant experience;
Must have proven track record for successfully leading and managing project teams;
Must be well-versed and affluent in Chemistry, Manufacturing, and Controls as well as 21 CFR Parts 50, 58, 211, 312, 314, Subchapter H (Medical Devices), and 45 CFR Part 46, as well as applicable FDA and ICH Guidances;
Must be able to obtain and maintain a Public Trust Security Clearance;
Must have 10 years of US FDA Regulatory Affairs experience;
Must be familiar with DocuBridge, FDA’s ESG and e-STAR programs, and validation software used for submitting regulatory documentation.
Preferred Qualifications. Regulatory Affairs Certification for US; experience with vaccine development; International Clinical trials experience; familiarity with NIH Institutes and its missions.
Original Posting
April 7, 2025
For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.
Pay Range
Pay Range $126,100.00 - $227,950.00
The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
#Remote
Salary : $126,100 - $227,950
