Regulatory Affairs Specialist

Employer
Azzur Group
Location
Bridgewater, NJ
Posted
Jun 30, 2017
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe


Job Description

Our client, a Fortune 50 company and Leader in the Pharmaceutical industry seeks a talented Regulatory Affairs Specialist to work on electronic Drug Master File (DMF) and Chemistry, Manufacturing and Controls (CMC) submissions.

Requirements:

B.A./B.S. degree; Regulatory Affairs certification preferred

Good understanding of scope and requirements and experience with CMC/DMF regulatory submissions

Good communication skills and proven organizational skills

Company Description
Azzur Group is a private company and comprised of several speciality companies Azzur Consulting, a GxP compliance and consulting organization dedicated to helping life sciences companies succeed. Our experienced staff specializes in manufacturing systems & equipment design, installation & startup, commissioning, and verification/qualification, computerized systems validation, process validation, project management and related functions. Azzur Consulting also offers GxP compliance and audit services related to regulatory inspection prep and inspectional finding remediation as well as general project management support. We are continuously updating and maintaining our knowledge base with the latest regulatory requirements, industry best practices, and inspectional trends to help our clients stay ahead.

Our team is a network of skilled problem solvers with broad experience across biotechnology, pharmaceuticals and medical device businesses. Our goal is to keep our clients at the top of their industry. After all, our success is determined by the success of our clients.


Bridgewater, NJ

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Mon, 26 Jun 2017 11:16:36 PDT

PI98466545