Regulatory Specialist

US$0.00 - US$73000.00 per annum
  1. Contract
  2. Consultant / Specialist
  3. United States
Milpitas, California
Posting date: 18 Mar 2019

ProClinical is advertising a vacancy for a Regulatory Specialist position with one of the largest workforce management solutions companies in the world. The organisation, which specialises in multiple scientific and engineering sectors, is seeking for an experienced and driven individual to join their team in California. This is an exciting opportunity to bring experience and skill whilst working with an expanding and dynamic company by working closely with the business and developing contacts.

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 labelling by editing and formatting documents while adhering to current regulatory guidelines, internal processes and procedures, style and document standards, and utilizing publishing tools, technology, and systems.
  • 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 labelling in accordance with internal procedures.
  • Maintaining document design consistence 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 environmental 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 (SOPs).
  • 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:

  • An Associate or Bachelor's degree, though a high school diploma or general education degree (GED).
  • 1 year of experience in regulatory affairs with a degree, or 1-2 years of related experience with the high school diploma or GED. Equivalent experience/training will also be considered.
  • A solid understanding of project management, documenting work, and completing projects on a time-sensitive basis.
  • 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.

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 contact Maya Smith at +267-405-6995 or upload your CV on our website -

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.