Director, Regulatory Affairs
Our client is looking to hire a Director of Regulatory Affairs for their Chicago, IL headquarters. This is a highly visible role because the Director of Regulatory Affairs will be responsible for leading and managing regulatory activities involving combination products for the company. My client has 10 combination products in pipeline, and these are complex products with interesting scientific challenges. Also, the Director of Regulatory Affairs will develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company.
- Regulatory lead for Combination Product Development at the company
- Development and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company
- Evaluate regulations, establish framework, and design and implement science-based registration strategies for combination products to ensure rapid, high quality submissions
- Work closely with Product Development team to define submission requirements for combination products and draft appropriate CMC sections
- Assess impact of project team decisions on the regulatory strategy, timelines and projects goals and advise/influence the team as needed
- Assist with the development CDPs for the company's R&D portfolio
- And many more
- Extensive experience working on the drug-device combination products in Regulatory Affairs
- Hands-on experience with Regulatory submissions - authored ANDAs, NDA 505(b)(2)s - Involved hands on with 4+ applications
- Experience advising development teams during development as it relates to combination product aspects of development
- Experience with the development of CDPs as the team completes these for all of the products
- Not a must requirement - experience working with Regulatory agencies, including the FDA
- Looking for someone who is easy to get along with, able to work in a fast-paced and an intense work environment, flexible, and willing to take the lead and drive certain projects
Sthree US is acting as an Employment Agency in relation to this vacancy.