Director of Regulatory Affairs Job

Employer Name:	SpiderID: 2232602
Location: Boston, Massachusetts	Date Posted: 5/21/2008
Wage:	Category: Biotech
Job Code:
Number Of Openings: 1

Job Description:
The Associate Director/Director of Regulatory Affairs is responsible for managing all regulatory aspects on pharmaceutical programs in various stages of development. The person will ensure that all details are managed efficiently and will have direct experience preparing regulatory submissions for development products.

Roles and Responsibilities include the following:

Independently represents department on assigned projects, making decisions outside the functional group on development programs
Translating domestic and foreign regulatory requirements and for providing guidance in a manner that effectively facilitates team decision making on development programs
Manages, prepares, and ensures the timely submission of well-organized and scientifically sound regulatory submissions
Maintain awareness of changes in regulatory requirements for effective submissions
Ensure accuracy and quality of regulatory submissions
Generate and/or review regulatory documents to ensure appropriateness with regulatory requirements, agreements, and regulations
Serve as regulatory liaison with the FDA and other regulatory agencies for assigned projects
Interpret and execute policies and plans affecting the department and assigned projects

Job Requirements:
Solid background in general biological/physical science and the ability to apply that knowledge to complex drug development issues within the framework of applicable regulatory requirements. Strong knowledge of US regulations. Track record in establishing effective FDA interactions that result in a partnership with the corporate development team
Strong written and verbal communication skills, including effective negotiation techniques.

Job Criteria:
Start Date:
Position Type:
Years of Experience Required: 7
Education Required: Doctoral
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: Jennifer Chance	Company Type: Recruiter
Company: Foundation Search Partners, LLC

City: Hickory
State: North Carolina
Zip: 28601