Sr. Regulatory Affairs Scientist

We need to output HTML fragment with sections: About the role? The posting includes description about company, but we need to follow rules: Use

for section headings (e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Include a section only when posting has real, specific content for it. Do not repeat job title as heading. Do not put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, etc. Also remove duplicated lines, application instructions. Preserve all substantive information. We need to parse the posting. Content: - Intro paragraph: "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." That's generic marketing, maybe we can treat as "About the role"? Actually "About the role" is a heading we can use for description of role. But the intro is about company, not role. However we could still put under "About the role" maybe summarizing? But we must not invent or summarize away detail. We need to preserve all substantive information. The intro is not about the specific role but about company. Could we drop it? It's not boilerplate? It's generic but maybe considered marketing fluff. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. This intro is not those categories. It's about the company. Might be considered relevant? The instruction says preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep it. But we need to place it somewhere. Could be a

before any heading? The output only HTML fragment; we can have

elements not under headings? The instruction says use

for section headings,

• for any list,

  for prose. It doesn't forbid having

  outside sections. But they said "Prefer a few substantive sections over many thin ones." So we could have a section "About the role" containing that intro plus responsibilities? Actually responsibilities are separate. We have responsibilities listed after "Responsibilities". That's a heading we can use. We have qualifications: "Possess a Regulatory Affairs Certification (RAC) Must be a US Citizen or full Green Card holder." That's a requirement. Also there is mention of "Tunnell strives to hire and retain the most qualified talent..." that's EEO boilerplate; we should remove EEO lines. Also "Please be advised that certain client contracts may outline specific requirements for onsite work." That's maybe a note but could be considered boilerplate? It's about compliance; maybe keep? It's not EEO but it's a generic statement. Might be considered boilerplate? The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. The line about client contracts may be considered legal? It's about compliance; could be considered legal boilerplate. Safer to remove. Also "Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols." Also legal boilerplate; remove. Thus we keep: company intro, responsibilities list, requirement (RAC, citizenship). Also maybe location and hybrid schedule: "Location: Fredrick, MD (Hybrid- two days a week on-site)". That's schedule/location info. Should we create a Schedule section? The posting states hybrid two days a week on-site. That's schedule info. According to rules: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text. So we can create a

  Schedule

  with

  Fredrick, MD (Hybrid- two days a week on-site)

  . Or maybe combine location and schedule. Pay/Benefits: not mentioned, so omit. Qualifications: we have RAC and citizenship. Could also include "Must be a US Citizen or full Green Card holder." That's a qualification. Could also include "Regulatory Affairs Certification (RAC)". That's a qualification. We could also have "Requirements" section for those. Or "Qualifications". The instruction list includes both Requirements and Qualifications as possible headings. We need to decide. Since we have specific requirements (certification, citizenship), we can put under

  Requirements

  with
  • Regulatory Affairs Certification (RAC)
  • US Citizen or full Green Card holder
  . We might also have "Skills" but not explicit. Responsibilities: we have a long paragraph with many duties. We should convert to
  • items. The text after "Responsibilities" includes a sentence: "The Contractor shall ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy including identifying and mitigating risk, and providing support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions." Then "Regulatory Affairs support includes but is not limited to the following:" then a list of items each starting with a verb. We need to capture all items. Let's extract each bullet: - Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure ORA leadership and the sponsor's representative are kept current on the progress of the program through periodic reports - Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team on any FDA-related activities and issues, and attending meetings, updating ORA leadership and the sponsor's representative through routine reports - Lead the development of a written regulatory strategy and provide to the Government The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government. - Create or provide input to and maintain Target Product Profiles and provide to the Government. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate. - Identify and mitigate regulatory risk through a project Risk Register. - Serve as the primary contact with the FDA for assigned products; review, analyze, and respond to FDA communications and meetings by the regulatory deadline and maintain meeting minutes in EDMS. - Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions in EDMS. - Participate and represent as regulatory subject matter expert in on-site visits at the industry partner manufacturing facility as requested - Provide regulatory assistance for Quality Management System assessments done at the manufacturing facility performed by ORA or external consultants - Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities - Enter information in ClinicalTrials.gov for clinical studies prior to study initiation. Provide quality assurance for the data and information entered, and ensure compliance with the current regulatory, DHA, and ORA requirements to include upload of required documents, record verification at least once every 6 months, and updates within 30 days for changes to recruitment status, sponsor IRB, approval etc. Enter clinical study results NLT 12 months after the study's primary completion date. - Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents. We need to preserve all substantive information. So each bullet as
  • . Now about company intro: maybe we can put under

    About the role

    with

    ...

    . But the intro is about company, not role. However we could still label as "About the role" and include that paragraph. It's not inaccurate; it's about the role's context. Might be acceptable. Alternatively we could have no heading and just a

    at start. But instruction says use

    for section headings; doesn't forbid having

    without heading. But they said "Prefer a few substantive sections over many thin ones." So better to have sections. Thus sections: About the role, Responsibilities, Requirements, Schedule. We'll omit Benefits, Pay, etc. Now ensure we don't include any boilerplate like EEO statements. Remove lines: "Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran." Also remove "Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols." Now produce HTML. We need to output only HTML fragment, no /, no markdown. Let's craft:

    About the role

    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.

    Responsibilities

    • Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure ORA leadership and the sponsor's representative are kept current on the progress of the program through periodic reports
    • Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team on any FDA-related activities and issues, and attending meetings, updating ORA leadership and the sponsor's representative through routine reports
    • Lead the development of a written regulatory strategy and provide to the Government. The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
    • Create or provide input to and maintain Target Product Profiles and provide to the Government. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
    • Identify and mitigate regulatory risk through a project Risk Register.
    • Serve as the primary contact with the FDA for assigned products; review, analyze, and respond to FDA communications and meetings by the regulatory deadline and maintain meeting minutes in EDMS.
    • Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions in EDMS.
    • Participate and represent as regulatory subject matter expert in on-site visits at the industry partner manufacturing facility as requested