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Associate II, Regulatory Submissions, Ukraine

Covance 5/24/2019 1:53:15 PM
JOB ID: 31656 Category: Regulatory
Kiev, Ukraine

   

 

Job Overview

Responsible for providing support to regulatory managers and others for the timely submission of information to Regulatory Authorities in support of investigational and marketed products. Interacts with Regulatory Authorities and with clients to support regulatory activities. Proactively interacts with other Covance groups and with clients to provide guidance regarding Regulatory Authority requirements and project timelines and requirements. It is the responsibility of the Regulatory Associate to prepare documents to the required standard and to maintain awareness of current regulatory standards related to submissions for drug and biologic products.

Essential Job Duties:

* Assist with the preparation of study documentation such as the core EudraCT Form (Annex I, II & III) and cover letter.
* Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g. INDs/CTAs and NDAs/MAAs/CTDs). May take ownership of specific pieces of work.
* Assist in the coordination, collection and organization of data and information required by Regulatory Authorities.
* Assist in client meetings and proactively liaise with clients on Regulatory Submission issues.
* Interact with the Publishing group, Copy Center or equivalent as necessary for the production of submissions.
* Maintain knowledge and awareness of regulation and guidelines pertaining to drugs and biologics.
* Monitor compliance with regulatory requirements in relation to assigned projects.
* Work on special regulatory projects as assigned.

Education / Qualifications

Bachelor's Degree in Life Sciences or equivalent

Experience

* Proven Experience in the Pharmaceutical industry, preferably in Regulatory Affairs or Drug Development
* Fluent English and local languages


Position Type: Full-Time

Location: Kiev, UKR - Ukraine



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If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

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If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

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Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).