Regulatory Operations Specialist

3 days ago


Oakville, Ontario, Canada Xcenda Full time

**About the Role:**

We are seeking a highly skilled Regulatory Operations Specialist to join our team. The successful candidate will be responsible for building and maintaining positive relationships with internal and external contacts, including interfacing with potential clients.

Key Responsibilities:

  • Use various internet document transfer sites to download client files and upload files ready to be sent back to our clients.
  • Manage and maintain submission files on the company shared drive and submissions drive as per company standard.
  • Create and format e-compliant documents as per clients' needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, Power Point.
  • Create eCTD submissions using the eCTD submissions builder, validation software and electronic submissions viewer.
  • Troubleshoot issues on a document level independently and on a submission level with the help of your manager.
  • Send eCTD submissions via the ESG and CESG gateway.
  • Burn CDs/DVDs, create appropriate labeling, and pack and ship submission materials as needed.

Requirements:

  • A B.Sc in Life Sciences or typically 3-5 years of daily working experience in Regulatory Operations.
  • Excellent written and verbal communication skills, computer skills, and previous experience with Microsoft Word and Adobe Acrobat.
  • Multitasking skills, attention to detail, and ability to work well individually and as a team.

About Us:

Cencora is a leading global pharmaceutical solutions company that connects manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We're a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures.



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