Senior Consultant, Regulatory Operations
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
- 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.
- 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
- Comprehensive Medical, Dental, and Vision Insurance
- 401(k) Plan for all Full-Time Employees
- Commuter Benefits
- Reimbursements for Health & Wellness Programs and Memberships
- Self-Managed Vacation Policy