About the role Build and maintain a positive and productive liaison with internal and external contacts Use various internet document transfer sites to download and upload files Create and format e-compliant documents using Microsoft Word and Adobe Acrobat Create eCTD submissions using the eCTD submissions builder Quality checking smaller, basic daily submissions Troubleshoot issues on a document level independently Send eCTD submissions via ESG and CESG gateway Create courier waybills and pack submission materials as needed Attend and contribute to weekly department meetings Requirements B.Sc in Life Sciences or typically 3-5 years of daily working experience in Regulatory Operations Excellent written and verbal communication skills Excellent computer skills (previous experience with Microsoft Word and Adobe Acrobat is an asset) Some previous experience with Excel and Power Point is an asset Experience with Non-eCTD electronic Submissions (NeeS) and eCTD software an asset Knowledge of industry guidance’s (Regulatory Operations related and some Regulatory Affairs related), would be an asset to have Ability to multitask with the aim of balancing several projects at once Must have a good understanding of client confidentiality 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 Excellent project management skills Medical, dental, and vision care Backup dependent care Adoption assistance Infertility coverage Family building support Behavioral health solutions Paid parental leave Paid caregiver leave Training programs Professional development resources Mentorship programs Volunteer activities Copy Applicant Tracking System Keywords Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills eCTD submissions document formatting quality checking troubleshooting Microsoft Word Adobe Acrobat Excel PowerPoint Non-eCTD electronic submissions Regulatory Operations
Soft skills communication skills multitasking client confidentiality time management organization prioritizing skills attention to detail teamwork project management results oriented