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Position:
Associate Director/Director, Regulatory Affairs
Employer:
Simcere of America Inc.
Description:
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Manage US Regulatory Affairs activities to develop and implement regulatory strategies for ANDA, 505b(2) and/or IND applications.
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Provide guidance to product development and regulatory team members in China regarding US FDA requirements and assure successful completion of regulatory affairs activities.
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Provide input for regulatory affairs requirements and regulatory affairs strategies in cross-functional meetings on product development to ensure timely submission.
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Review and make final determinations for regulatory affairs assessments of proposed CMC changes
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Responsible for reviewing, revising, performing gap analysis and ensuring completeness and accuracy of the content of US regulatory affairs submissions.
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Manage, plan, compile, review and submit all regulatory affairs dossiers in a timely manner.
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Direct communications and interactions with FDA and other regulatory affairs agencies worldwide as applicable.
Qualifications/Experience:
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B.S. degree and/or above in a scientific discipline or equivalent, 3 to 10 years’ experience in the pharmaceutical industry, minimum 3 years in Regulatory Affairs.
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Experience in Oral Solid Dosage form, small molecule ANDA products. Experience in injectable is a plus
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Hands on experience in pre-approval and post-approval process
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Knowledge of drug product development, manufacturing process, and lifecycle management.
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Detail oriented, good organizational and communication skills with cross-functional teams internally and externally in a dynamic environment
Preferred:
- Experience in project management
- Chinese and English bilingual
Location:
Princeton, NJ
Contact:
Chen Chen (chen.chen@simcereusa.com)
Post Date:
11/6/2018 2:12:36 PM
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