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Regulatory Affairs Specialist
Raleigh, NC 27513 United States
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.
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.
North Carolina Biotechnology Center