Consultant, Project Associate (Regulatory Affairs)

Remote within U.S. Option Available


Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively and push beyond the status quo? Join Halloran Consulting Group, Inc. today!


Halloran is looking for a Consultant, Project Associate with a Regulatory focus to join its Consulting Operations practice area. As a Consultant, Project Associate, you will be responsible for establishing project timelines, providing subject matter support for projects, identifying opportunities for project expansion and assisting with devising support strategy.


Characteristic Duties:

  • Assists with the deliverables associated with the project; may be responsible for deliverables independently
  • Executes assigned Regulatory Affairs-focused tasks in scope of work, which may include:
    • Start-to-finish project coordination including writing the SOW, driving the timeline and managing the budget
    • Assisting with FDA requests and regulatory filings such as progress and safety reports
    • Helping to coordinate the submission process for Pre-IND, IND, or NDA
    • Managing FDA correspondence and supporting FDA interactions
  • Executes assigned Project Management tasks, which may include:
    • Meeting coordination, agenda preparation, and meeting minutes
    • Budget management
    • Project plan development and maintenance
    • Slide development
    • Additional administrative tasks
  • Communicates directly with the project team/project lead and client if required
  • Ensures deliverables meet the time, quality, and resource standards
  • May support project lead and Subject Matter Expert (SME) for customer deliverables
  • Will act independently on limited scope project deliverables
  • Contributes to deliverables according to the following criteria:
    • Focuses equally on results (high-quality deliverables that meet objectives); process (use of logical and efficient processes to achieve results); and relationships (engendering the client’s trust and goodwill among team members)
    • Targets personnel for appropriate levels of involvement and decision-making
    • Participates in meetings effectively to facilitate decisions, according to good meeting management practices
    • Alerts manager and engagement lead to any work conflicts preventing fulfillment of responsibilities, giving enough lead time to address resource issues
    • Manages time effectively, notifying engagement lead and manager of extra capacity when appropriate
  • Will learn and expand SME knowledge
  • Will support project lead on growing new business with client and identify opportunities to expand the engagement with the client
  • Identifies business development opportunities in existing clients and educates clients on Halloran Services
  • Performs other duties and responsibilities as assigned




  • Bachelor’s Degree and a minimum of four years of Regulatory Affairs, Regulatory CMC, or Regulatory Operations experience in pharmaceutical, biotechnology, or medical device companies
  • Extensive experience with Microsoft Word, Microsoft PowerPoint, Adobe Acrobat Professional, Microsoft Excel, and Microsoft Project or Excel


  • Experience with IND Submissions
  • Regulatory Operations/Publishing experience
  • Early stage clinical trial experience
  • Experience with scientific, medical, or technical writing
  • Experience with electronic document management and publishing software
  • Advanced degree or certification in a relevant area


Halloran Consulting Group, Inc. Perks:

  • Comprehensive Medical, Dental, and Vision Insurance
  • 401(k) Plan for all Full-Time Employees
  • Reimbursements for Health & Wellness Programs and Memberships
  • Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
  • Self-Managed PTO Policy
  • Commuter FSA Benefits



Our company is committed to equal employment opportunities for all applicants and employees.  We will not discriminate against employees or applicants for employment based on any protected class including, but not limited to race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.


In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.


No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by a member of Halloran’s Human Resources or Talent Acquisition teams.


Halloran Consulting Group | Consultant, Project Associate (Regulatory Affairs)