Associate Director / Director Regulatory Affairs Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2348905
Location: Columbia, Maryland	Date Posted: 7/7/2008
Wage:	Category: Medical/Health
Job Code:

Job Description:
Associate Director / Director Regulatory Affairs The selected candidate for the Associate Director Regulatory Affairs position will be responsible for compiling and processing US IND, CTD, Annual reports, DMF, NDA and BLA submissions and assisting with all Regulatory Affairs /Quality Assurance department needs. In this role, you will ensure timeliness of deliverables; edit/format/review regulatory documents; and work with staff in resolving regulatory issues and/or problems. Ensure that the company adheres to all applicable regulations. Additionally, you may serve as the team member for specific projects; be responsible for gathering and entering regulatory information related to specific projects; perform regulatory and/or quality assurance reviews of data or reports; attend project meetings, professional meetings, seminars and workshops; and document all phases of involvement in any specific project. The qualified candidate will have a bachelor's degree in the life sciences or equivalent, along with 10 years of experience in the pharmaceutical or CRO industry with at least 3 of these years as a regulatory affairs Manager or higher level. The candidate must be experienced in writing and compiling regulatory documents (i.e. (INDs, NDAs, BLAs, DMFs, FDA meeting packages, IBs, etc.), Hands-on strategic regulatory planning experience is preferred. Excellent attention to detail, written and verbal communication and computer skills are required. Experience: See Job Description

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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