Regulatory Affairs Coordinator

Highly Competitive Salary
  1. Permanent
  2. Publishing & Submissions
  3. United States
Irvine, California
Posting date: 29 Aug 2019

Proclinical is currently recruiting for a Regulatory Affairs Coordinator for our client located in Irvine, CA. Successful candidate will provide support to the Regulatory Affairs department to manage Coordination of training for all RA staff globally, coordinate records maintenance, manage Purchase Orders under budget constraints and lead all administrative duties as requested.

Job Responsibilities:

  • Prioritize daily tasks associated with records coordination, Purchase Orders, publishing and archiving/coordination of regulatory submissions records.
  • Identify documents and files that need to be archived.
  • Provide periodic updates on training requirements and records maintenance to department staff. Assist in ensuring compliance to all procedures, applicable standards, and regulations.
  • Support during regulatory and supplier/distributor audits.
  • Assist in regulatory submission authorship and compilation.
  • Perform other duties as assigned.

Skills and Requirements:

  • 1+ years' experience in Regulatory Affairs or equivalent.
  • Must be proficient with MS Office applications.
  • Ability to take direction and find solutions in ambiguity
  • Excellent communication skills (verbal and written).
  • Strong organizational skills.
  • Ability to problem solve, recognize and find solutions for gaps in processes.
  • Project management skills.
  • Ability to work both independently and in a team environment.
  • Problem solving skills.
  • Quality and process improvement oriented.
  • Attention to detail.

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) 267-983-0134 or upload your resume 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.

Proclinical Staffing is an equal opportunity employer.