REGULATORY AFFAIRS ASSOCIATE I

Proclinical is currently seeking a Regulatory Affairs Associate I for a biotechnology company located in Foster City, CA. Successful candidate will provide support in the preparation of routine regulatory activities for commercial or investigational products in line with ICH requirements, regional requirements, and scientific and company policies and procedures.

Job Responsibilities:

• Working to develop and acquire required regulatory skills and knowledge, with guidance from immediate manager.
• Contributing to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
• Performing workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
• Seeking assistance from appropriate internal and external resources.

Skills and Requirements:

• BA/BS in a scientific field is preferred.
• Strong organizational and attention to detail, along with the ability to work on several projects with tight timelines.
• Strong verbal and written communication skills and interpersonal skills.
• Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas.
• Proficiency in Microsoft Word and Excel.
• Experience with Microsoft Power Point, Project and Visio a plus.
• May act as a resource on a specific topic for other Regulatory personnel within the department.
• Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures.

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 Sherron Howard at (+1) 267-435-8600 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.

#LI-SH1
#Regulatory