Associate, Regulatory Operations

• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with (potential) clients.
• Use various internet document transfer sites to download client files and upload files ready to be sent back to our 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 the team to promote growth and new business
• Assist in writing marketing materials, if required.
• Maintain professional regulatory and documentary knowledge in order to provide effective consulting advice.
• The Associate is the periodic back-up responsible for coordinating work. Ensuring all submissions and communications are covered fully, accurately, and completely to the department standards.
• Effectively manage and prioritize both billable and unbillable work.
• As needed, effectively delegate work to ensure all submissions are available for external QC in a timely manner; meeting assigned deadlines.
• Assist with the creation and review of process documentation/SOPs.
• The Associate will be involved with training of other department members as needed, on a software, document, and submission level.
• Publish, validate, and submit XML Product Monographs and SPLs if assigned by their manager, including independently troubleshooting and fixing any issues..
• Create ASCII datasets as needed if assigned by their manager.
• Troubleshoot and mitigate IT issues within the department and provide systems-related support if assigned by their manager.
• Lead and complete PRCI projects if assigned by their manager. This includes collaboration and coordination with team members, answering questions, providing advice, creation of timelines, and tracking project status.
• The Associate may be asked to complete additional and other department services as required.

• B.Sc in life sciences and/or 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. Fluent in English, both written and spoken.
• Exceptional computer skills in advanced Microsoft Word, Adobe Acrobat, Excel, and PowerPoint.
• Advanced technological skills.
• High knowledge of Non-eCTD electronic Submissions (NeeS).
• Has a complete and thorough knowledge of all eCTD software used at Innomar, once training is complete.
• 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.

Cencora