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Job: Director, Regulatory Affairs, Advanced Recruiting Partners, Raleigh, NC


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General Information

(3608403)

Job title: Director, Regulatory Affairs
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Job location: Raleigh, NC  27513 United States
Requisition code:
Date posted: 04/18/2017
Compensation:
Job category:Clinical Research
Employment type:Full time
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Job Description


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Position Summary:

The Director, Regulatory Affairs will be the primary 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 managing 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 or Master’s degree preferred or equivalent experience in pharmaceutical/biotech and clinical research management. Eight to ten 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.
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