Senior Consultant, Regulatory Operations

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 Senior Consultant, Regulatory Operations to join its Regulatory Affairs practice area. As a Senior Consultant, Regulatory Operations, you will be responsible for managing multiple regulatory programs for emerging biotechnology and pharmaceutical companies, overseeing the submission of regulatory documents to the FDA, providing guidance on eCTD publishing standards, and developing reference guides and tools for regulatory submissions. Additionally, you will assess current Halloran systems and take a leadership role in proposing and implementing new aspects for regulatory processes, coordinate electronic signature systems, and provide regulatory operations training to new hires, Halloran teams, and client teams.

Characteristic Duties:
  • Develop and lead operational aspects of Regulatory Operations systems and processes as well as standardization for deliverables to ensure consistent, high quality output and processing
  • Manage the operational aspects of all regulatory submissions, while ensuring high quality and timely submissions
  • Liaise with the regulatory lead on the submission timeline, content, and deliverables
  • Liaise with the electronic submissions vendor
  • Manage the internal resources needed to execute electronic submissions
    • Allocate resources to format, build, QC submissions
    • Perform formatting, building, and QCing activities
  • Overseee the resources needed to execute paper submissions, as needed
    • Allocate resources to build & QC paper submissions
  • Oversee the maintenance or tracking tools for planned  and past regulatory submissions
  • Oversee the maintenance of the CTD template library
  • Create and maintain Halloran Style Guide
  • Coordinate electronic signature system
  • Provide format training to new hires, and remedial training as needed, for MS Word and Adobe documents
  • Develop reference guides and tools for regulatory submissions
Qualifications:

Required:

  • Bachelor’s degree in life science, business or management with at least twelve years of Regulatory Operations experience in a biotech or pharma setting
  • Experience with implementing new document management/publishing systems
  • Experience interacting with publishing companies
  • High proficiency in Microsoft Word, Excel, Adobe Acrobat Professional, Project, and PowerPoint

Preferred:

  • Experience with electronic publishing software
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
Notice:

Our company is committed to equal employment opportunity.  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.

 

Halloran Consulting Group | Senior Consultant, Regulatory Operations