ASSOCIATE DIRECTOR GLOBAL GENERICS REG AFF Job Listing at The Judge Group in IL

Business Services

Job ID: 377473
Job Title: ASSOCIATE DIRECTOR GLOBAL GENERICS REG AFF
Job Type: Permanent
Company: JUDGE GROUP
Location: Illinois
Contact E-mail: LMANFREDY@judge.com
Salary: Open
Description:
Associate Director Generics Global Regulatory Affairs needed for one of our clients. In this role you will lead a team of regulatory professionals in delivering core dossiers that will form the basis for generic regulatory submissions globally and to support the timely and effective registration of the generic product portfolio in the US. Oversee the development and implementation of global regulatory strategies to support the registration of the generics portfolio. Provide regulatory advice to global project teams to inform R and D activities and ensure the generation of high quality data to support product registrations across the globe. Support the global regulatory development process through to approval, including preparation of regulatory meeting strategies and documentation, interface with global regulatory authorities, critical review of regulatory core dossiers and query response strategies and execution. Oversight of the development of US registration packages, key contact with the FDA and management of the review process to meet business objectives for the US. Bachelor degree required. Five years of experience in regulatory affairs or related field, global experience preferred. Ten years of experience in the pharmaceutical, biotech and/or medical device industry desired.