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Job (this posting is now closed/inactive)

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General Information


Job title: Regulatory Affairs Specialist
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Job location: Raleigh, NC  27513 United States
Requisition code:
Date posted: 04/21/2017
Job category:Regulatory Affairs
Employment type:Full time
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Job Description

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Position Summary:
The Regulatory Affairs Specialist will be the secondary point of contact for identifying and communicating global regulatory changes and will provide global support to the Quality & Regulatory Compliance operations. This role will include completing regulatory submissions, monitoring and communicating changes in regulations and database training.
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Job Requirements

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Education/Experience Requirements:
Bachelor’s degree preferred or equivalent experience in pharmaceutical/biotech and clinical research.

Three to five years of experience in drug safety and pharmacovigilance, quality management principles
and systems and/or drug development working with clinical and/or post-marketing products. Previous
regulatory experience preferred.

Knowledge, Skills and Abilities:
Ability to work in an environment of rapidly changing priorities and workload; ability to manage multiple activities and assignments; ability to work both as a member of a team and in an independent, self-directed manner; ability to manage and organize work to meet timelines and to meet the attention of detail required to successfully complete assignments; ability to communicate effectively in English, both orally and in writing; ability to present information in front of groups of people; ability to maintain client and corporate confidentiality; ability to effectively negotiate with individuals at all levels of business; ability to make sound decisions relating to the advancement of the company mission and goals; ability to effectively interact with the multi-national community; and ability to proficiently utilize MS Office and other required software.

Essential Duties and Responsibilities:
* Client Regulatory Submissions
* Regulatory Expedited Submissions
* Aggregate Reporting Submissions
* Working on Quality Compliance Initiatives
* Compiling Regulatory intelligence for multiple countries
* Assist in the development of Client Specific Guidelines and Regulatory Report Matrix for every client.
Create and maintain a template for client onboarding. (both client and companywide)
* Assist monitor and communicate changes in regulations. Investigate and provide data driven analysis
of global regulations.
* Assist the Director, Regulatory Affairs with monitoring regulatory changes and communicate this through company newsletters, lunch n learns, etc.
* Assist QRC Department as needed
* Other duties as assigned.
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