Regulatory Affairs Manager CMC
|Job Title:||Regulatory Affairs Manager CMC|
|Contact Name:||Pavlina Bullaj|
|Job Published:||March 01, 2017 16:02|
Sr. Manager Regulatory Affairs CMC
SciPro Global are currently looking for a Sr. Manager Regulatory Affairs CMC professional. We are working with one of our key clients - a Seattle based Biopharmaceutical Company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for disorders of the CNS.
Working on a number of clinical-stage development programs across different CNS disorders, the client is currently looking for a Sr. Manager Regulatory Affairs CMC professional to come in and contribute to the development of the CMC regulatory strategy appropriate to the stage of product development.
As part of your role, you will be responsible for driving the content for the Regulatory Affairs CMC submissions - such as but not limited to IND/CTA, NDA/MAA. Additionally, you'll also be responsible for coordinating the preparation of CMC submissions through editing and approval of final draft documents including review for quality.
- Coordinating preparation of information and related activities for CMC meetings with health authorities
- Interacting with domestic and foreign regulatory agencies on CMC issues
- Serving as the regulatory representative at project meetings and interacts with personnel from corporate partners in order to achieve common goals
- Negotiating, interacting with, and supervising the activities of contract manufacturing organizations (CMO's) in the preparation of regulatory submissions
- Managing regulatory CMC activities within time and budgets for approved project plans
- Communicating project status and issues
- BS/MS degree in Chemistry or other scientific discipline
- Minimum 10 Years related experience and/or training in the pharmaceutical
- Minimum of 5 years in CMC regulatory
- Significant experience interacting with at least one major health agency eg FDA
If you think this is something you would be interested in, please apply directly & I will be in contact shortly, alternately please call me on 415 621 9281 for more information.
I look forward to hearing from you!
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