REGULATORY AFFAIRS ASSOCIATE II

Proclinical is currently seeking a Regulatory Affairs Associate II for a biotechnology company located in Foster City, CA. Successful candidate will be responsible for preparing regulatory submissions which require some interactions with other members in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.

Job Responsibilities:

• Participating in group meetings and providing tactical approaches to addressing issues of moderate complexity.
• Responsible for developing and acquisitioning of required regulatory skills and knowledge, with manager support.
• 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
• Performing document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
• 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.

Knowledge and Skills

• 4+ years of relevant training or industry experience with BS/BA.
• 3+ years relevant training or industry experience with advanced degree.
• Degree in a scientific field is preferred.
• Strong organizational and attention to detail, along with the ability to work several of projects with tight timelines.
• Strong verbal and written communication skills and interpersonal skills.
• Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
• Proficiency in Microsoft Word and Excel.
• Experience with Microsoft Power Point, Project and Visio a plus.
• Act as a resource on limited topics within the department.
• Work is performed under the general supervision of more senior Regulatory Affairs professionals and is reviewed for soundness of judgment and overall adequacy.

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.

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