Manager CMC Regulatory and Compliance Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2334150
Location: Cambridge, Massachusetts	Date Posted: 7/2/2008
Wage:	Category: Medical/Health
Job Code:

Job Description:
24099 MANAGER CMC REGULATORY AND COMPLIANCE - req 24099 Bristol-Myers Squibb (Syracuse, NY) The successful candidate will be responsible for the global CMC regulatory strategy for maintenance of biologics marketed products. This position entails participation on various cross functional project teams, strong interaction with Technical Operations personnel at manufacturing sites and other key partners both internal and external to the company. The position will have responsibility for providing global regulatory assessments for anticipated analytical, manufacturing and packaging changes, compilation of post approval regulatory submissions including annual reports, renewals, supplemental applications, variations and other maintenance dossiers and coordination of responses to health authority questions comments. This position requires the ability to manage multiple projects and to prioritize work independently. With management participation, this position will interact directly with the FDA and with other Health Authorities through local regulatory managers. EDUCATION PREFERRED Minimum BS, Chemical Engineering, Pharmacy, Chemistry, Biology or related science. An advanced degree is an asset. YEARS OF EXPERIENCE PREFERRED 5+ years in the Pharmaceutical Industry and 3+ years biologics CMC regulatory strategy or related experience in biologics analytical development or manufacturing. LIST MAJOR SKILLS REQUIRED The preferred candidate will have a strong knowledge of global CMC regulations and guidances pertaining to biologics, exposure to developing global regulatory strategies for post approval changes, and direct experience in handling health authority questions and responses. The candidate should have an understanding of the pharmaceutical business and experience in building favorable relationships with key partners. The preferred candidate will have demonstrated ability to be a strong team member both within and outside the department. This position requires good organizational, communication, electronic systems and project management skills. Please apply to req 24099 at www.bms.com « Back to list

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Position Type: Full-Time Permanent
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Company: PharmaceuticalCrossing

City: Pasadena
State: California
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Web Site: http://www.pharmaceuticalcrossing.com