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Global Regulatory Intelligence Specialist

Covance 10/30/2018 12:18:26 PM
JOB ID: 24027 Category: Regulatory
Maidenhead, United Kingdom



Job Overview

The Drug Device Safety Solutions & Adjudication group is seeking a Global Regulatory Intelligence Specialist to join their team in either Maidenhead or Edinburgh. In this position, you will collect global regulatory requirements and coordinate maintenance of the global repository. Additional responsibilities include:

* Maintain thorough understanding of the safety submissions requirements and processes for global regulatory authorities, ethics committees, and investigators
* Constantly monitor relevant sources of regulatory requirements
* Identify applicable documents that require attention for assessment and provide strategic recommendations for active participation to new and revised draft requirements, for comments to draft requirements, or for implementation
* Communicate strategic recommendations and participate in decision about applicability, owner of actions, implementation plan
* Execute decision, as applicable, and communicate and train on regulatory requirements
* Improve the data collection and review process for regulatory filings, surveys, analysis, and reporting
* Support development of departmental tools and processes and SOPs in accordance with the regulatory requirements
* Act as SME for the safety reporting submission processes and systems
* Support internal, external, and regulatory audits and inspectionsSupport Drug Safety project managers and operational team members with the project deliverables related to regulatory/EC/ site submissions

Education / Qualifications

* Bachelor's degree preferred; however, a combination of education, training, and Experience will be considered


* At least 3 years of Experience with safety regulatory processing and regulatory reporting
* At least 1 year of Experience with monitoring and maintenance of regulatory intelligence
* Thorough understanding of EU reporting requirements is highly preferred
* Some Experience in supporting and attending audits and inspections
* In-depth understanding of global regulatory requirements including FDA, EMA, CFDA, PMDA, etc.
* Experience working with cross functional project teams and the ability to understand complex requirements
* Proven ability to work in a fast paced environment and handle multiple projects simultaneously
* Strong verbal and written communication skills; proven ability to translate technical documentation into effective regulatory submissions
* Strong organization skills for systemic monitoring of regulations

Position Type: Full-Time

Location: Maidenhead, UK - United Kingdom


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

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 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).