Highly Competitive Salary
  1. Permanent
  2. Publishing & Submissions
  3. United States
Jacksonville, Florida
Posting date: 22 Jul 2019

Proclinical is currently seeking a Regulatory Specialist for its client located in Jacksonville, FL. Successful candidate will be responsible for the preparation of internal Regulatory documentation and various document types to be used in dossiers and labeling, both in paper and electronic formats.

Job Responsibilities:

  • Preparing, dispatching and filing routine Regulatory Affairs documentation, including but not limited to 30-day Notices, DTF, HA correspondence in paper and electronic format.
  • Preparing high quality submissions and labeling by editing and formatting documents.
  • Performing routine operational tasks including but not limited to publishing, archiving and uploading of documents to document management systems.
  • Collecting required documents, scans, etc. to complete routine submission packages.
  • Organizing electronic structures for local storage of regulatory submissions and/or labeling in accordance with internal procedures.
  • Maintaining document design consistency for all documents to ensure compliance with company document design standards, including the use of predetermined templates.
  • Participating in other key regulatory projects including but not limited to external environment monitoring
  • Performing final formatting and appropriate rendering of documents for filing and submission, including version control and document handling, to maintain regulatory compliance.
  • Following established standard operating procedures.
  • Assisting with the monthly reporting of data for established metrics.
  • Meeting personnel paperwork due dates, e.g., timesheets.
  • Staying current with changes of internal procedures.
  • Interacting with employees in a collegial and professional manner.
  • Remaining current with all assigned training.

Skills and Requirements:

  • AA/AS or BA/BS 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.
  • 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.
  • Good verbal and written communications.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) (+1) 267-983-0134 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.