Director, Regulatory Operations

We need to output HTML fragment with sections: Overview (maybe as

Overview

), Responsibilities (

Responsibilities

), Qualifications (

Qualifications

), Benefits (

Benefits

), Pay (

Pay

), Schedule? Not present. Also maybe "Company Description" not needed as heading? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to include sections for Overview, Responsibilities, Qualifications, Benefits, Pay. Possibly also "Company Description"? Not required; we can embed as part of Overview? The posting includes "Company Description" and "Overview". The "Overview" is a paragraph describing role. We'll treat that as Overview section. We need to remove boilerplate: EEO, accommodation contact, application deadline maybe? The instruction says remove application instructions. The posting includes "The Company anticipates the application deadline for this job posting will be 9/28/2026." That's application instruction? It's not exactly instruction but maybe considered metadata; we can drop it. Also "If you require accommodation or assistance with the application or onboarding process specifically, please contact USMTTACompliance@publicis.com." That's boilerplate; drop. Also "All your information will be kept confidential according to EEO guidelines." drop. Also "Compensation Range: ..." we keep as Pay section. Also benefits details: "Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off." Also later: "For regular roles, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off." We'll combine. We need to preserve all substantive info. So include details about responsibilities list, qualifications list, benefits list, pay range. We must not include sections with placeholder text. All sections have content. We need to use

• for any list of duties/requirements/benefits. So responsibilities list, qualifications list (maybe bullet list), benefits list. We need to use

  for prose. We must not output markdown code fences, only HTML fragment. Let's craft:

  Overview

  The Director, Regulatory Operations is responsible for ensuring the smooth daily operations of the team of employees who submit materials for regulatory review by CoLab's external clients. The Director also supports teams with managing their clients’ review processes including participation in client planning and presentations. Internally, the Director is responsible for continuous process improvement throughout CoLab in guiding materials through review and ensuring awareness of changing regulatory environment. The Director is responsible for ensuring the entire department has the support required to complete their work. They must be a creative problem solver with projects and with their team. They are also responsible for identifying any potential pitfalls or challenges and ensuring they are escalated to senior leadership in a timely manner.

  Responsibilities

  • Provide leadership, career guidance and training opportunities for the department staff
  • Manage multiple direct reports at the Senior Manager, Manager, Associate and Senior Associate level including responsibility for interviewing, hiring, onboarding, and career development
  • Manage workload across regulatory review department
  • Work with staffing, recruiting, and individual business managers to determine workload projections to ensure all client needs are met
  • Escalate potential large issues and concerns to senior leadership
  • Work with external clients to establish appropriate regulatory review procedures where procedure has previously been lacking
  • Advise external clients on streamlining their reviews
  • Work with new external clients to uncover and document their review procedures
  • Contribute to new business development efforts
  • Train DH personnel on FDA regulations and the MLR review process
  • Serve as an advocate for the Regulatory Review Department internally and in front of external client

  Qualifications

  • Minimum of a bachelor's degree and 6-9 years of experience in the preparation of complex deliverables under tight deadline constraints is required with at least 3 years of management experience.
  • Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous pharmaceutical industry or healthcare experience is required.
  • Technical competency in Internet Explorer, Adobe Acrobat, and the Microsoft Office Suite are required.
  • Extensive experience communicating with and presenting to clients is required.
  • Clear communication and attention to detail are essential.
  • Clear, concise technical writing ability is strongly preferred.
  • At least 5 years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required.

  Note: This job specification should not be construed to imply that these requirements are the exclusive standards of the position. Performs other duties (or functions) as assigned.

  Benefits

  • Medical coverage
  • Dental
  • Vision
  • Disability
  • 401K
  • Parental and family care leave
  • Family forming assistance
  • Tuition reimbursement
  • Flexible time off
  • Paid time off (for regular roles)

  Pay

  Compensation Range: USD $106,780.00 - USD $170,937.00/Annually.

  We should also maybe include a short paragraph about company description? Not required as heading; we could embed in Overview? But we have Overview already. The company description could be omitted as not required heading. The instruction: "Prefer a few substantive sections over many thin ones." We have Overview, Responsibilities, Qualifications, Benefits, Pay. That's fine. Check for any leftover boilerplate: We removed EEO, accommodation, application deadline. Also removed "Publicis Groupe motto ..."? That's part of benefits description? Actually it's a paragraph about motto and inclusive benefits. That is substantive? It describes benefits philosophy; we could incorporate into Benefits section as prose maybe. But we already have benefits list; we could add a

  before list describing motto. The instruction: preserve ALL substantive information; do not invent or summarize away detail. So we should keep the motto paragraph. It's not a list; we can put as

  before the

  . Let's include. Thus Benefits section:

  Benefits

  Our Publicis Groupe motto “Viva La Différence” means we’re better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent. Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive.

  ...list...
  Also there is sentence: "Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off." That's essentially same as list; we can keep list and maybe not duplicate. But we should preserve that sentence; we could incorporate as prose before list. However we already have motto paragraph; we could add another paragraph describing benefits package. To avoid duplication, we could keep the sentence as prose and then list items. But the list already includes those items; having both prose and list may duplicate but it's okay as preserving info. However we might be duplicating content; but instruction says preserve ALL substantive information; duplication is okay as long as we don't omit. We'll include both. Thus Benefits section:

  Benefits

  Our Publicis Groupe motto “Viva La Différence” means we’re better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent. Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive.

  Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.

  ...list...
  But the list items repeat the same; we could keep list only and drop the sentence to avoid redundancy. However the instruction says preserve ALL substantive information; if we drop the sentence we lose that specific phrasing. But the list includes the same items; the sentence is essentially a summary of the list. It's arguably redundant but still substantive. Safer to keep both. Now Pay section: we have compensation range. Also there is sentence: "Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time." Also "Temporary roles may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. For regular roles, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off." That's more about benefits; we already covered benefits. Could add to Benefits section. But we already have benefits list; we could add a sentence about temporary roles. However we already have benefits list; we could add a

  about temporary roles. Let's incorporate into Benefits section after list maybe. But we need to avoid duplication. We'll add a

  after list: "Temporary roles may be eligible to participate in our freelancer/temporary employee medical plan through a third-party benefits administration system once certain criteria have been met. For regular roles, the Company will offer medical coverage, dental, vision, disability, 401k, and paid time off." Now Pay section: include compensation range and the sentence about determination and right to modify. Thus Pay:

  Pay

  Compensation Range: USD $106,780.00 - USD $170,937.00/Annually.

  Consistent with applicable law, compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position, and the Company reserves the right to modify this pay range at any time.

  Now ensure we didn't include any heading like "About the role" etc. We used Overview, Responsibilities, Qualifications, Benefits, Pay. Check for any leftover boilerplate: We removed EEO, accommodation contact, application deadline, maybe also "Note: This job specification should not be construed..." we kept as note