Manager of Regulatory Affairs (Device/CMC)
A multinational, pharmaceutical company with a strong generics portoflio sold gloablly is looking to hire a Manager of Regulatory Affairs for their Columbus, OH 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 primary responsibility for this Manager of Regulatory Affairs will be to focus on regulatory filing strategy for combination medical devices used with sterile injectable drug products, drawing upon their expertise in CMC. These products are the 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.
Requirements:
* 8+ years of experience
* Strong CMC expertise
* Previous work with 510k Applications
* Experience with ANDA and 505(b)(2) submissions
Qualifications that Stand Out:
* Prior experience with sterile injectable products
* Experience reviewing device DMFs (MAFs)
* Prior management experience
