Senior Regulatory Operations Specialist
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
Responsibilities:
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Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with (potential) clients.
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Use various internet document transfer sites to download client files and upload files ready to be sent back to our clients.
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Use, manage, and maintain submission files within company systems as per company standard.
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Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, and Power Point.
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Create eCTD submissions using an eCTD submissions builder, validation software, and an electronic submissions viewer.
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Create NeeS submissions, as needed, and coordinate any necessary shipments.
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Quality check and provide accurate feedback on all submission types.
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Independently troubleshoot and fix issues on a document and submission level.
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Send eCTD submissions via the ESG NextGen Portal.
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Save submissions to external media and arrange for parcel delivery (if required).
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Enter time into the company time recording system on a daily basis.
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Attend and contribute to weekly department meetings, helping bring innovative solutions to the team to promote growth and new business
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Assist in writing marketing materials, if required.
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Maintain professional regulatory and documentary knowledge in order to provide effective consulting advice.
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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.
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Effectively manage and prioritize both billable and unbillable work.
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As needed, effectively delegate work to ensure all submissions are available for external QC in a timely manner; meeting assigned deadlines.
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Assist with the creation and review of process documentation/SOPs.
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The Associate will be involved with training of other department members as needed, on a software, document, and submission level.
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Publish, validate, and submit XML Product Monographs and SPLs if assigned by their manager, including independently troubleshooting and fixing any issues..
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Create ASCII datasets as needed if assigned by their manager.
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Troubleshoot and mitigate IT issues within the department and provide systems-related support if assigned by their manager.
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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.
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The Associate may be asked to complete additional and other department services as required.
Education:
- B.Sc in life sciences and/or typically 5-7 years of daily working experience in Regulatory Operations
Skills:
- 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).
- Has a 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.
- Has a complete understanding of client confiden