Regulatory Affairs Specialist

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real content. We need to parse the posting. Title: Regulatory Affairs Specialist (not to be repeated as heading). Company: Health Research, Inc. (HRI) Roswell Park Division. Department: Clinical Trials Office. Time Type: Full time. Weekly Hours: 40. FTE: 1. Shift: First Shift (United States of America). Summary: description. We need to extract responsibilities, requirements, qualifications, skills, benefits, pay, schedule. Let's read the posting: "Ensures that Roswell Park IND’s/IDE’s and other regulatory submission types are in compliance with FDA regulations; keeps current on changes in regulations for drugs, biologics, devices and tobacco products; advises investigators on FDA requirements as they apply to the specific application which includes pre-clinical, pharmacological, toxicology, chemistry, manufacturing and control of investigational agents; interprets and applies FDA regulations to investigational product applications and provides regulatory input, advice, guidance to the investigators; maintains and tracks FDA regulatory submissions electronically." That's responsibilities. "The pay range for this position is $77,308- $95,503 annually which includes a comprehensive benefits package. The listed pay range reflects the range of potential compensation for this role. The actual offer may vary based on qualifications, skills, and experience. We are recruiting for multiple candidates on this posting!" So Pay: $77,308- $95,503 annually. Benefits: comprehensive benefits package (maybe mention). Could also list benefits but not detailed. Qualifications: Required Education and Experience: Certification Requirement: Current certification by RAPS preferred; or ability to secure RAC within three (3) years of employment. Education and Experience: Bachelor’s degree and the equivalent of four (4) years of full-time research experience, two (2) years which must have been in regulatory affairs, clinical research or a related field involving FDA regulations. Note: Incumbents must obtain a Regulatory Affairs Certification (RAC) from RAPS within three (3) years of appointment to this position as a condition of continued employment. Required degrees must have been granted by an accredited school, college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices. Preferred Qualifications: The preferred candidate will have, Research Certification, Document management experience and Knowledge of FDA regulations. We also have other metadata: Job Type Regular, Department Clinical Trials Office, Time Type Full time, Weekly Hours 40, Fte 1, Shift First Shift (United States of America). That could go under Schedule? Actually schedule: First Shift, 40 hours per week, full-time. So we can include Schedule section with those details. Benefits: "comprehensive benefits package". Could also mention maybe other benefits not listed. We'll just include that. We need to remove boilerplate: EEO statement, Affirmative Action, Reasonable Accommodation, Core Values, Grant Funding, E-Verify, etc. Also remove duplicated lines. Now structure: We need headings: maybe About the role (summary), Responsibilities, Requirements (maybe combine Qualifications?), Qualifications, Skills, Benefits, Pay, Schedule. But we must not create sections with filler. So we need to decide which sections have content. We have summary (About the role). We have responsibilities (list). We have qualifications (required and preferred). We could split into Requirements (maybe required) and Qualifications (preferred) but the instruction says use headings like Requirements, Qualifications, Skills. We can include both. We have Skills: maybe from preferred qualifications: Research Certification, Document management experience, Knowledge of FDA regulations. Could be considered skills. We have Pay: salary range. We have Benefits: comprehensive benefits package. We have Schedule: Full time, 40 hours weekly, First Shift. We need to use

• for any list of duties/requirements/benefits. So responsibilities list as ul. Requirements list as ul. Benefits list as ul (maybe just one item). Skills list as ul. We need to use

  for prose. We must not repeat job title as heading. We must not put Job ID/requisition numbers as headings (none present). We must output only HTML fragment. Let's craft. First, maybe a short paragraph for About the role (summary). Could be

  Ensures that Roswell Park IND’s/IDE’s and other regulatory submission types are in compliance with FDA regulations; keeps current on changes in regulations for drugs, biologics, devices and tobacco products; advises investigators on FDA requirements as they apply to the specific application which includes pre-clinical, pharmacological, toxicology, chemistry, manufacturing and control of investigational agents; interprets and applies FDA regulations to investigational product applications and provides regulatory input, advice, guidance to the investigators; maintains and tracks FDA regulatory submissions electronically.

  Then Responsibilities: Actually the summary already covers responsibilities; but we could treat that as About the role. Could also have Responsibilities section with same content as list. But we need to avoid duplication. The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we need to keep the summary info. We could put it in About the role paragraph. Then Responsibilities could be a list of duties derived from same sentences. But that would be duplicative. However we could keep the summary as About the role and not have a separate Responsibilities section, or we could have Responsibilities as a list and omit the paragraph. Which is better? The instruction: Prefer a few substantive sections over many thin ones. So we could combine summary and responsibilities into one section maybe About the role (or Responsibilities). Since the summary is essentially responsibilities, we could make a Responsibilities section with list items derived from the semicolon-separated duties. That would preserve all detail. Then we might not need About the role. But we need a heading for section; we could use

  Responsibilities

  and list. But we also have other sections like Qualifications, Skills, Benefits, Pay, Schedule. Thus we could have:

  Responsibilities

  • Ensures that Roswell Park IND’s/IDE’s and other regulatory submission types are in compliance with FDA regulations
  • Keeps current on changes in regulations for drugs, biologics, devices and tobacco products
  • Advises investigators on FDA requirements as they apply to the specific application which includes pre-clinical, pharmacological, toxicology, chemistry, manufacturing and control of investigational agents
  • Interprets and applies FDA regulations to investigational product applications and provides regulatory input, advice, guidance to the investigators
  • Maintains and tracks FDA regulatory submissions electronically
  That captures all. Then Qualifications: we have required education/experience and certification requirement. Could be list. We could have

  Qualifications

  with subpoints maybe required and preferred? But we also have Skills section for preferred qualifications. Let's separate: Required Qualifications under Qualifications, and Preferred Skills under Skills. Thus:

  Qualifications

  • Bachelor’s degree and the equivalent of four (4) years of full‑time research experience, with at least two (2) years in regulatory affairs, clinical research or a related field involving FDA regulations
  • Current certification by the Regulatory Affairs Professionals Society (RAPS) preferred; or ability to obtain RAC within three (3) years of employment
  • Must obtain a Regulatory Affairs Certification (RAC) from RAPS within three (3) years of appointment as a condition of continued employment
  • Degree must be from an accredited institution or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices
  Then Skills:

  Skills

  • Research certification
  • Document management experience
  • Knowledge of FDA regulations
  Pay:

  Pay

  $77,308 – $95,503 annually (includes a comprehensive benefits package)

  Benefits: maybe we could mention benefits package but we already included in Pay. Could still have Benefits section with

  Comprehensive benefits package

  . But to avoid duplication, maybe we just keep Pay includes benefits. However instruction: include a section ONLY when posting has real, specific content for it. Benefits: posting says "includes a comprehensive benefits package". That's specific enough. So we can have Benefits section with that sentence. Schedule:

  Schedule

  Full‑time, 40 hours per week, First Shift

  We also have Department, Job Type Regular, etc. Could be included in About the role? Not needed. Could add a short paragraph for "About the role" maybe includes department and job type. But we already have Responsibilities covering duties. The posting also includes "Job Type Regular", "Department Clinical Trials Office", "Time Type Full time", "Weekly Hours 40", "Fte 1", "Shift First Shift (United States of America)". Some of that is captured in Schedule (full-time, 40 hours, first shift). Department and Job Type could be added to a brief About the role paragraph. But we might not need a separate About the role section if we already have Responsibilities. However we might lose some info like department and job type. The instruction: Preserve ALL substantive information. So we need to include department and job type somewhere. Could add a short paragraph after Responsibilities maybe under "About the role" heading. But we must not repeat job title as heading. "About the role" is allowed. Thus we could have:

  About the role

  Position: Regulatory Affairs Specialist at Health Research, Inc. (HRI) Roswell Park Division, Clinical Trials Office. Regular, full‑time position (40 hours/week, first shift).

  That captures job type, department, schedule details (though schedule also separate). Might be redundant but okay. But we already have Schedule section with full-time, 40 hours, first shift. So About the role could just mention department and job type. Let's decide: We'll have About the role with department and job type. Then Responsibilities list. Then Qualifications list. Then Skills list. Then Pay. Then Benefits. Then Schedule. Check for duplication: Schedule mentions full-time, 40 hours, first shift. About the role mentions regular, full-time position (40 hours/week, first shift). That's duplication but maybe okay. Could we drop About the role and instead include department and job title in a paragraph under Responsibilities? Not ideal. Maybe we can incorporate department and job type into a brief paragraph under "About the role" without repeating schedule details. Eg: "Regular position in the Clinical Trials Office at Health Research, Inc. (HRI) Roswell Park Division." Then Schedule section covers hours/shift. Thus About the role:

  Regular position in the Clinical Trials Office at Health Research, Inc. (HRI) Roswell Park Division.

  That preserves department and job type. Now we need to ensure we don't include boilerplate like EEO etc. Now produce HTML fragment. Let's craft:

  About the role

  Regular position in the Clinical Trials Office at Health Research, Inc. (HRI) Roswell Park Division.

  Responsibilities

  • Ensures that Roswell Park IND’s/IDE’s and other regulatory submission types are in compliance with FDA regulations
  • Keeps current on changes in regulations for drugs, biologics, devices and tobacco products
  • Advises investigators on FDA requirements as they apply to the specific application which includes pre‑clinical, pharmacological, toxicology, chemistry, manufacturing and control of investigational agents
  • Interprets and applies FDA regulations to investigational product applications and provides regulatory input, advice, guidance to the investigators
  • Maintains and