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10 days old

Regulatory Specialist I

Kelly Services
Jacksonville, FL 32232
**Regulatory Specialist I - Jacksonville FL**


Kelly Services is currently seeking a Regulatory Operations Specialist for a long-term engagement with one of our Global Pharmaceutical clients in Jacksonville, FL.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Summary:**


The Regulatory Specialist is a key documentation expert for the Regulatory Affairs department. This individual is responsible for finalization of internal Regulatory documentation and various document types to be used in dossiers and labeling, both in paper and electronic formats, and responsibilities may extend to coordination, compilation, assembly, and publication of routine and complex regulatory dossiers and labeling, both in paper and electronic formats. Concentration may be on a region in addition to global knowledge.


**Responsibilities:**


+ Prepares, dispatches and files routine Regulatory Affairs documentation

+ Collaborates with Regulatory Affairs staff to assure adequate prioritization, preparation and dispatch of routine regulatory submissions and/or labeling creation

+ Finalizes high quality submissions and labeling by editing and formatting documents while adhering to current regulatory guidelines, internal processes and procedures, style and document standards and utilizing company publishing tools, technology, and systems.

+ Performs operational tasks including publishing, archiving and uploading of documents to document management systems; organizes and maintains components of regulatory submissions and labeling including template preparation, scanning, printing or filing.

+ Collects documents to import, edit and/or create in electronic documentation storage and retrieval systems.

+ Establishes and organizes electronic structures for local storage of regulatory submissions and/or labeling, including migration and maintenance of regulatory documents.

+ Participates on project teams for the publishing of regulatory documents and labeling creation.

+ Assists in preparing training materials and conducting training for users of electronic documentation systems and authors of regulatory documents.

+ Maintains document design consistency for all documents to ensure compliance with company document design standards, including the use and maintenance/creation of templates.

+ Performs final formatting and appropriate rendering of documents for filing and submission, including version control and document handling, to maintain regulatory compliance.

+ Follows established and/or creates new (as needed) standard operating procedures.

+ Responsible for maintaining all assigned work aids, etc.

+ Responsible for monitoring updates to HA regulations related to dossier formatting/assembly and assessing the impact on the business process.

+ Assists with the monthly reporting of data for established metrics.

+ Meets personnel paperwork due dates, e.g., timesheets.

+ Independently solves routine problems and develops solutions.

+ Recommends changes to current processes to make them more effective and efficient.

+ Stays current with internal procedures as well as regulatory changes and information, typically within a region.

+ Interacts with employees in a collegial and professional manner.


**Requirements:**


+ Associate or Bachelors degree; or 1-3 years experience in regulatory affairs; or high school diploma or general education degree (GED) with 3 to 5 years related experience; and/or training or equivalent combination of education and experience.


+ Experience with regulatory processes and standards, including document standards and electronic document management systems (EDMS).

+ Working knowledge of Health Agency regulations for the assigned region and industry standards pertaining to regulatory operations.

+ Ability to work independently with regular supervision.

+ Strong organizational skills, accuracy and attention to detail

+ Ability to complete assigned tasks efficiently with some direction

+ A team player who is able to work in a fast-paced environment.

+ Understanding of guidelines and regulations around technical submission requirements for assigned region and/or deliverables.

+ Should possess a self-starting personality.

+ Software knowledge: Windows, MS Office (advanced skills required), Adobe Acrobat Professional (advanced skills required), ISI toolbox (advanced skills required), StartingPoint Templates (advanced skills required), Submission publishing tools, XML and SML authoring tools,

+ Good verbal and written communications


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-15 Expires: 2021-10-16

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Regulatory Specialist I

Kelly Services
Jacksonville, FL 32232

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