Regulatory Affairs Specialist

Highly Competitive
  1. Permanent
  2. Consultant / Specialist
  3. United States
Jacksonville, Florida
Posting date: 02 Apr 2019
RA.MS.22499_1554213849

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Regulatory Affairs Specialist position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Florida-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

The Regulatory Specialist will be a key documentation expert for the Regulatory Affairs department and will prepare 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, and HA correspondence in paper and electronic format.
  • Preparing 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.
  • Performing routine operational tasks, including but not limited to, publishing, archiving, and uploading 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 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:

  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Maya Smith at +267-405-6995or upload your CV 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.

#LI-MS2

#RegulatoryAffairs

close