Regulatory Affairs Specialist

At Proclinical, we are seeking an experienced individual to fill the role of Regulatory Affairs Specialist, based in Orange County, CA. The successful candidate will provide support for the regulatory team by creating regulatory documentation, providing input into strategy development and reviewing documentation as needed.

Responsibilities

• Work with core team lead to execute deliverables per project schedule.
• Attend meetings and provide regulatory guidance as needed.
• Assist in the creation of registration documentation.
• Under supervision, create renewal documentation.
• Perform regulatory impact assessments for design/manufacturing changes.
• Medical writing.
• Labeling.
• Change assessment.
• Compendial/standards.
• Import/export.
• Country specific regulatory support - specifically European Regulatory Requirements.

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 Mary Jacobs at (+1) 2674774800 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.