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Associate II, Regulatory Submissions, Sofia

Covance 4/27/2018 1:17:16 PM
JOB ID: 19596 Category: Clinical Operations
Sofia, Bulgaria

   

 

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.

Responsibilities:

* Assist in the preparation of routine submissions filed to Regulatory Authorities (e.g.: INDs, CTAs, NDAs, NDSs, MAAs or CTDs). May take ownership of specific pieces of work
* Contribute to the preparation of submissions to Health Authorities by reviewing/summarizing scientific/research documents
* Assist in the coordination, collection and organization of 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 regulations and guidelines pertaining to drugs and biologics
* Monitor compliance with regulatory requirements in relation to assigned projects

Education / Qualifications

Bachelor's Degree in Life Sciences or equivalent

Experience

* Excellent communication skills, organization and planning skills and attention to detail
* Proven Experience in the pharmaceutical industry, preferably in drug development or regulatory affairs
* Core and Leadership competencies: Focus on Customers, Innovate and Change, Pursue Scientific and Process Excellence, Work with Others, Achieve Results.


Position Type: Full-Time

Location: Sofia, BGR - Bulgaria



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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.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

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.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

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).