Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.

Regulatory Operations Subject Matter Expert

Essential duties and responsibilities include but are not limited to the following. Other duties may be assigned :

• Follow BARDA submission requirements in consideration of BARDA Program Divisions and the regulatory operational requirements of BARDA core services including clinical, nonclinical, and manufacturing network services
• Conduct cross-functional training on submission practices, procedures, and systems as needed
• Review and edit documents in electronic Common Technical Document (eCTD) format associated with submissions to regulatory authorities
• Provide editing review of draft and final documents prepared by other writers before internal and external distribution
• Convert documents to Portable Document Format (PDF) and ensure they meet the FDA PDF specifications
• Responsible for the management, design, publishing, review, submission, and archive of eCTD submissions, including amendments and original filings
• Responsible for staying abreast of US, regulations, as applicable and Harmonized (ICH) eCTD Guidance, and providing training as required
• Responsible for troubleshooting and resolving publishing technical issues
• Coordinate publishing and submitting of all electronic dossiers and documents to regulatory authorities and/or clients
• In collaboration with the management of Regulatory Operations manage scheduling and tracking of submissions
• In collaboration with the management of Regulatory Operations, develop, update, maintain and disseminate information on BARDAs eCTD Processes
• Liaise with Regulatory Affairs Project Managers, and CROs directly, as necessary, to coordinate submission timelines and technical specifications and for client eCTD reviews
• Provide Regulatory Operations support by researching regulations and guidance's as it applies to eCTD submissions and specialized submissions
• Assist BARDA personnel and CROs with document-level requirements and techniques for compliant upstream eCTD authoring
• Assist with document-level publishing, formatting, paper submissions compilation, and document quality control
• Ensure document content and style adheres to appropriate regulatory guidelines, and complies with agency SOPs and style guidelines

• Recognized Regulatory Operations expert with a minimum of 10 years progressive experience in leading regulatory operational activities supporting drug, biologic, and device development regulated by the Food and Drug Administration (FDA)
• Expert knowledge of FDA submission types and management of FDA submissions compliant with the eCTD specification
• Experienced with electronic publishing software and advanced PDF processing tools
• Expert knowledge of FDA and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) content requirements for CTD dossiers
• Knowledge of and experience in document-level formatting and publishing.
• Understanding of the eCTD structure as well as US, publishing guidance's, as applicable and ICH specifications for electronic publishing
• Superior competency in MS Word, experience with Accenture StartingPoint preferred Superior competency in Adobe Acrobat and ISIToolbox™ and/or other PDF toolset(s)
• Ability to build XML documents using Lorenz or similar publishing software.
• Ability to self-train in areas that are not part of the routine processing for eCTD Submissions (i.e., CSR publishing, PEUA, EUAs)
• Willingness to work in a hands-on capacity. Ability to work both independently and in a collaborative team setting and successfully build relationships with internal teams.
• Demonstrable track record managing projects of significant scope and complexity while meeting all deliverables and timelines
• Excellent verbal and written communication skills. Ability to effectively present information to management
• Excellent organizational and time management skills
• Exceptional listener and able to follow directions without continuous supervision
• Able to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills)
• Shows high-level attention to detail; is accurate and meticulous

Education :

• Bachelor's Degree or equivalent degree, qualification, and experience.

Tunnell is proud to be an Equal Opportunity / Affirmative Action / Female / Minority / Disabled / Veteran Employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, child-birth, or related medical conditions), national origin, ancestry, age, disability, family care status, veteran status, marital status, military status, sexual orientation, gender identity, or any other characteristic protected by law. Tunnell makes reasonable accommodation for persons with disabilities to apply for employment.

Please be advised that some of our client contracts, including contracts with the federal government, require us to validate that our employees and contractors are fully vaccinated against COVID-19, subject to legal requirements. If you are selected for this role or assignment, you will be required to confirm that you are fully vaccinated or engage in an interactive dialogue with Human Resources to determine if you are eligible for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm.