Manager of Regulatory Affars (Devices/CMC)
Columbus, Ohio
A multinational pharmaceutical company looking to hire a Manager of Regulatory Affairs for their Berkeley Heights, NJ location.
This organization is involved in a wide variety of therapeutic areas such as cardiovascular, neuroscience, oncology, respiratory, and more. For 2019 their generics operating profit that is up 33% as a result of commercial execution and reduced costs, along with 108 new products being launched across all markets to expand their global portfolio.
The ideal candidate will be able to draw upon prior work in the generics industry, and have experience in CMC, ANDA, NDA, and 510k applications. The primary responsibility of this role will be to focus on regulatory filing strategy for combination medical devices used with sterile injectable drug products. These products staple of this company and will allow this Manager to further build upon the financial success that is allowing them to branch out into other areas of the pharmaceutical industry.
