Regulatory Affairs Associate

Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in San Mateo, CA.

Job Responsibilities:

• Responsible for preparing regulatory submissions in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Responsible for development and acquisition of required regulatory skills and knowledge.
• Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
• Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.

Skills and Requirements:

• 1-3 years of relevant experience, a bachelor's degree or higher in a scientific field, knowledge of regulatory requirements and ICH guidelines, and experience with preparing regulatory submissions.
• Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.
• Strong verbal and written communication skills and interpersonal skills.
• Proficiency in Microsoft Word and Excel (Power Point, Project and Visio are a plus).

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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.

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