Pharmaceuticals, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
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. In this role, you will be responsible for managing all regulatory operations activities for emerging biotechnology and pharmaceutical companies. This includes ensuring accurate and on-time submissions of regulatory documentation to health authorities, implementing 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.
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
Education and Experience Requirements:
Bachelor’s degree in life science, business or management with 12-14 years of experience in a biotech, pharma, or regulatory submission service setting
Experience with implementing new document management/publishing systems
Experience interacting with publishing companies
Experience with electronic publishing software
Highly proficient in Microsoft Word and Adobe Acrobat Professional
Working business knowledge of Project, Excel, and PowerPoint
Characteristics of Top Performers:
Excellent communication and presentation skills
High energy and relentless passion to improve human health
Ability to work with multiple companies on multiple programs
Ability to lead independently with exceptional organization and attention to detail
Big-picture thinker with an ability to drive the details when necessary
Comfortable with ambiguity and high-pressure situations
Flexible and able to adjust/change course based on data, feedback, client request, etc.
Successful collaborator with clients and internal management and an ability to coach team members
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
Self-Managed Vacation Policy
Telecommuting is allowed.
Internal Number: 111
About Halloran Consulting Group, Inc.
In life science, every new drug or medical device springs from the drive to improve human health. In 1998, Laurie Halloran realized that the life science companies she worked with needed senior-level expertise to navigate the regulatory, clinical, and operational challenges facing each stage of development.
Halloran Consulting Group, with a growing team of industry experts, can help you find a solution.