Regulatory Operations Associate

Highly Competitive
  1. Permanent
  2. Officer /Associate
  3. United States
San Francisco, California
Posting date: 25 Apr 2019

A global research-based global biotechnology company is seeking for a Regulatory Operations Associate position to join their office in San Francisco. This organization focuses on molecularly-targeted and immuno-oncology cancer therapeutics. ProClinical is pleased to announce this exciting opportunity to work with an organization that employs over 2,000 employees worldwide.

Job Responsibilities:

  • Manage and maintain correspondence and other records in regulatory tracking system
  • Coordinate exchange of records using document-sharing platforms
  • Generate reports and reconcile data
  • Archives/retrieves archived regulatory documents (both paper and electronic) as necessary.
  • Ensure that all documents are maintained in a Central Records facility and are organized and identified so that they can be easily retrieved.
  • Coordinate regular transfer of the department's inactive records to and from offsite storage.
  • Ensure that records are maintained in accordance with current procedures and the Records Retention Schedules.
  • Assist in providing solutions to a variety of routine streamlining and technology problems.

Skills and Requirements:

  • Working knowledge of Microsoft Office and Adobe systems.
  • Ensures that all documents required by regulations or SOPs are maintained in a Central Records facility and are organized and identified so that they can be easily retrieved.
  • Has a working understanding of the regulations and processes that govern the content and maintenance of controlled documents required by the FDA and ICH.
  • Library science skills preferred.
  • Works under general supervision and follows established procedures.
  • 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 Mary Jacobs at +267-477-4800 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.