Senior Regulatory Operations Specialist

Role Overview

• Build and maintain a positive and productive liaison with internal and external contacts
• Use various internet document transfer sites to download client files and upload files ready to be sent back to clients
• Use, manage, and maintain submission files within company systems as per company standard
• Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, and Power Point
• Create eCTD submissions using an eCTD submissions builder, validation software, and an electronic submissions viewer
• Create NeeS submissions, as needed, and coordinate any necessary shipments
• Quality check and provide accurate feedback on all submission types
• Independently troubleshoot and fix issues on a document and submission level
• Send eCTD submissions via the ESG NextGen Portal
• Save submissions to external media and arrange for parcel delivery (if required)
• Enter time into the company time recording system on a daily basis
• Attend and contribute to weekly department meetings, helping bring innovative solutions to promote growth and new business
• Assist in writing marketing materials, if required
• Maintain professional regulatory and documentary knowledge to provide effective consulting advice
• Coordinate work ensuring all submissions and communications are covered fully, accurately, and completely to department standards
• Effectively manage and prioritize both billable and unbillable work
• Effectively delegate work to ensure all submissions are available for external QC in a timely manner
• Assist with the creation and review of process documentation/SOPs
• Involved with training of other department members, as needed
• Publish, validate, and submit XML Product Monographs and SPLs if assigned
• Create ASCII datasets as needed if assigned
• Troubleshoot and mitigate IT issues within the department and provide systems-related support if assigned
• Lead and complete PRCI projects if assigned
• Complete additional department services as required

Requirements

• B.Sc in life sciences
• Typically 5-7 years of daily working experience in Regulatory Operations
• At least 5+ years of daily hands-on Regulatory Operations experience minimum
• Exceptional understanding of a wide variety of submission types (Cdn and U.S.)
• Excellent written and verbal communication skills
• Exceptional computer skills in advanced Microsoft Word, Adobe Acrobat, Excel and Power Point
• Advanced knowledge and skills in IT
• High knowledge of Non-eCTD electronic Submissions (NeeS)
• Complete and thorough knowledge of all eCTD software used at Innomar
• Excellent understanding of Regulatory Operations industry guidances and a general understanding of Regulatory Affairs industry guidances
• Ability to multitask and balance several projects and ad-hoc requests at once
• Complete understanding of client confidentiality and the importance not to cross project information with one another
• Results oriented with proven time management, organization and prioritizing skills
• Must have an acute ability for attention to detail
• Ability to work well individually and as a team
• Responsibility for company supplied hardware and software; contacting Innomar IT when needed for assistance
• Ability to manage independently and obtain individual and department goals
• Excellent project management skills – expected to see all projects through to completion

Benefits

• Medical, dental, and vision care
• Backup dependent care
• Adoption assistance
• Infertility coverage
• Family building support
• Behavioral health solutions
• Paid parental leave
• Paid caregiver leave
• Professional development resources
• Mentorship programs