Senior Regulatory Operations Specialist

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🕒 June 24

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• 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