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RA Specialist I (1612) in Santa Ana, CA at Integrated Resources, Inc

Date Posted: 1/11/2019

Job Snapshot

Job Description

Position Description
Regulatory Specialist I
SUMMARY:
The Regulatory Specialist I is a key documentation expert for the Regulatory Affairs department. This individual is responsible for preparation of internal Regulatory documentation and various document types to be used in dossiers and labeling, both in paper and electronic formats.
RESPONSIBILITIES:
Prepares, dispatches and files routine Regulatory Affairs documentation, including but not limited to 30-day Notices, DTF, HA correspondence in paper and electronic format.
Prepares 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 Client publishing tools, technology and systems.
Performs routine operational tasks including but not limited to publishing, archiving and uploading of documents to document management systems.
Collects required documents, scans, etc. to complete routine submission packages.
Organizes electronic structures for local storage of regulatory submissions and/or labeling in accordance with internal procedures.
Maintains document design consistency for all documents to ensure compliance with company document design standards, including the use of predetermined templates.
Participates in other key regulatory projects including but not limited to external environment monitoring
JOB FUNCTION:
Performs final formatting and appropriate rendering of documents for filing and submission, including version control and document handling, to maintain regulatory compliance.
Follows established standard operating procedures.
Assists with the monthly reporting of data for established metrics.
Meets personnel paperwork due dates, e.g., timesheets.
Stays current with changes of internal procedures.
QUALIFICATIONS:
Ability to perform most duties under direct supervision
Good organizational skills, accuracy and attention to detail
Ability to complete assigned tasks efficiently with direction
A team player who is able to work in a fast-paced environment.
Software knowledge: Windows, MS Office (intermediate skills required), Adobe Acrobat Professional
Associate or Bachelors degree; or up to 1 year experience in regulatory affairs; or high school diploma or general education degree (GED) with 1 to 2 years related experience; and/or training or equivalent combination of education and experience.
Strong verbal and written communications
Excellent time management and organizational skills and previous experience working in an office environment are required