Regulatory Affairs I

ID# DCNJ27292

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

The Regulatory Affairs Associate position will work under the direction of a senior regulatory professional and will be responsible for supporting new product development activities, and ensuring compliance with local regulatory requirements. Primary responsibilities include providing input to regulatory strategies to product development teams for multiple regulatory classifications (i.e., drug, device, cosmetics), preparing Health Authority applications when needed (e.g., IND, NDA or 510(k)), and review and approval of product labeling, advertising, and promotion. 

Qualifications 

A minimum of a Bachelors degree in health-related science or life science field is required. A minimum of 2 years of industry experience in Regulatory Affairs, R&D, and/or Quality is required. A working knowledge of U.S. FDA requirements and guidelines is required plus an eagerness to learn and seek out internal and external subject matter expertise. Superior interpersonal, communication, problem-solving, and organization skills with attention to detail are a must. Proficient in the use of technology including MS Office Software Packages, Internet research, etc. Must be able to work successfully within a team environment and as an individual contributor.

Position Details:

Consumer Product

Clinical Research

Start Date: 
10-7-2013
End Date: 
12-31-2014

SKILLMAN, NJ

CON_W2

40

DCNJ27292

No

No