DIRECTOR, REGULATORY AFFAIRS 

The Associate Director/Director, Regulatory Affairs will help develop strategy and be an active partner in drug development project planning and execution.  You will be a major contributor in driving clinical program execution as well as work with regulators to gain global approval and marketing access to these new therapies. 

Must have expert knowledge of overall Regulatory functions to ensure acceptable Regulatory submissions for global compliance and submissions.  

Responsible for providing the expertise needed in translating clinical and nonclinical regulatory requirements into practical strategic regulatory plans.  Pushing these strategies forward through coordination, authorship development of domestic and global drug applications and submissions and through regulatory agency interactions.

Must be comfortable with authoring and compiling FDA and Ex-US regulatory applications and submissions, INDs, CTAs, information and protocol amendments, annual reports, meeting briefing documents NDAs.  

Must have:

Previous NDA experience, Advanced degree with at least 5 years of increasing Regulatory experience, solid working knowledge of relevant domestic and global regulations and guidance and a strong history of successful interactions with global regulatory authorities.

Are you interested in joining a fast-paced forward-thinking organization?  You will be a major contributor and valued member of a of critical thinkers who believe passionately in what they are accomplishing and what they can accomplish.  Don't let this opportunity slip away.  

Please call Cecelia at 240-464-0156 or email at cecelia@morrisexecutivesearch.com