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Associate Director Global Regulatory Affairs Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2447032 |
| Location: Pearl River, New York |
Date Posted: 8/22/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 7610116 |
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Job Description:
A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Job Summary Manages regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies. Acts as direct liaison with regulatory authorities to facilitate the prompt review and approval of applications. Leads and/or participates in Regulatory Teams for assigned projects/products. Negotiates complex issues with Agencies. Functional Summary - Responsible for managing the regulatory aspects related to chemistry, manufacturing and controls, for new and existing projects/products. Develops robust, global CMC strategies to ensure identification of key issues. Develops risk assessment and mitigation plans. Discusses/negotiates with regulatory agency(ies) in support of new dossiers and life-cycle management. Job Responsibilities Participates on RA Teams or committees as team leader and/or member. Serves as principal GRA representative to Interdepartmental development, CCC or brand teams. Assists in enhancing the professional growth of GRA team members by providing personal guidance and training relative to their responsibilities.
For more information, please click here to visit us at PharmaceuticalCrossing
For further information, please visit us online at http://www.pharmaceuticalcrossing.com
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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 |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.pharmaceuticalcrossing.com
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