ASSOCIATE DIRECTOR REG AFFAIRS, STRATEGIC L Job Listing at The Judge Group in IL

Business Services

Job ID: 377488
Job Title: ASSOCIATE DIRECTOR REG AFFAIRS, STRATEGIC L
Job Type: Permanent
Company: JUDGE GROUP
Location: Illinois
Contact E-mail: LMANFREDY@judge.com
Salary: 125-160k
Description:
Associate Director Regulatory Affairs, Strategic Labeling needed for one of our clients. Responsible for development of and execution against the regulatory labeling strategy and documentation for marketed products and products in development. Lead cross-functional teams in the timely development of content for a new or revised CCDS, USPI, SmPC and EM label for all products. Lead the development, review, approval, and implementation process for all USPIs and provide oversight of this process for SmPCs and EM labels.Maintain a centralized labeling repository for global labels at various stages of development, review, and approval. Bachelor Degree in pharmacy, biology, chemistry, pharmacology, engineering, or related required. 7 to 10 years in Regulatory, R and D or related area with at least 4 years of experience in labeling or equivalent experience within the pharmaceutical industry. Solid working knowledge of drug development process and FDA labeling; knowledge of and experience with EU, Asia and Emerging Market labeling desirable