Director, Regulatory and Strategic Development

Job Overview:

A Director of Regulatory and Strategic Development will be responsible for the primary delivery of or oversight and management of allocated projects including regulatory authority licenses, registrations, exemptions, designations, applications or authorizations for marketing and sale of a drug product or for the use of an investigational drug in human subjects.

This position will develop regulatory plans and strategies for emerging and mid-tier life science client companies.

The position will include client and regulatory authority liaison and requires excellent technical and verbal and written communication skills.

The position may include the supervision and management of regulatory professionals and support personnel.

Job Duties and Responsibilities:

Core:

·Prepare technical content for and review of regulatory documentation and submissions.

·Provide regulatory guidance internally to project teams,...