Regulatory Affairs Program Manager

SciPro Global are currently looking for a Regulatory Affairs Program Manager. 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 Regulatory Affairs Program Manager to come in and manage the regulatory tasks within time and budgets for approved project plans. This will include advising on the context and applicability of functional regulatory requirements for each assigned program appropriate to the stage of product development as well as coordinating the drafting, editing and preparation of regulatory submissions.

Responsibilities:

• Ensuring the content and accuracy of regulatory fillings
• Overseeing and ensuring that the regulatory files and systems are maintained in accordance with department procedures, compliance standards, laws, and regulations
• Interacting with domestic and foreign regulatory agencies on assigned projects
• Serving as the regulatory representative at project meetings and interacting 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
• Communicating project status and issues
• Supervising the activities of regulatory associates and assistants

Education/ Experience:

• BS/MS degree in a life science or a related field
• Minimum of 5 - 7 years of regulatory affairs experience in the biopharma industry
• Minimum of 2 years in drug development

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!