Associate Director, Clinical Regulatory Affairs Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2359070
Location: Piscataway, New Jersey	Date Posted: 7/10/2008
Wage:	Category: Medical/Health
Job Code: 6299512

Job Description:
We are passionate about providing best-in-class customer service through innovative partnerships, technologies and processes. We are focused on seizing opportunities and delivering results. It\'s all part of our continuing commitment to Growth Through Innovation. Our Pharmaceuticals Division is searching for Associate-Director, Clinical Regulatory Affairs, in Piscataway, NJ who reports to Director, Regulatory Affairs. Basic Function: * The Associate Director acts as the initial regulatory resource for clinical development activities on assigned projects, providing functional area leadership to the team and managing the project activities of other regulatory staff assigned to projects under their authority. Responsibilities: * Responsible for coordinating the drafting, editing and preparation of regulatory submissions, (e.g., INDs, NDAs, annual reports, IND amendments, NDA supplements, routine correspondence). * May direct interactions with drug regulatory agencies (US and non-US) on defined matters for assigned projects. * Serves as the primary Regulatory Affairs representative to assigned clinical development teams(s) and interacts with other departments and with personnel from corporate partners. * Responsible for organizing regulatory submission teams and coordinating the editing and preparation of clinical module or clinical content of regulatory submissions, (e.g., INDs, NDAs, annual reports, IND amendments, NDA supplements, routine correspondence). * Coordinates preparation of clinical information and related activities for meetings with drug regulatory agencies. * May be responsible for interactions on defined matters with drug regulatory agencies for assigned projects including the conduct of meetings and preparation of accurate meeting minutes. * Participates in development of overall project goals and in particular those that pertain to clinical regulatory affairs. * Participates in regulatory strategy and position papers for clinical development candidates, submissions, drug regulatory agency meetings and special regulatory issues.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.pharmaceuticalcrossing.com