Associate, Regulatory Operations

Cencora•Watertown, CT

About The Position

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! This posting is intended to fill an existing vacancy for our Associate, Regulatory Operations role.

Requirements

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.
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 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.
Has a positive attitude and works for the greater good of our clients, the team and the company.
Is responsible 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. Expected to take on, as assigned, with little to no assistance from Director of department. Expected to coordinate with RA and Regulatory Operations team members, and keep them apprised on submission status, in order to complete all projects on time. Independently able to identify, trouble shoot and fix any issues which arise. Correct document placement within the eCTD structure is understood. Submissions should have virtually no errors upon first validation. Able to identify, at all times during project, any progress on any specific task. Coordinates, on their own, any project management meetings needed and reports back to Director any needed information. Expected to keep accurate, up-to-date records as per company/department guidelines.
Ability to consistently meet extremely tight deadlines.
Excellent conflict resolution capabilities and ability to spearhead issues (professionally) and successfully solve as they arise.

Responsibilities

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.