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Position:
Associate Director/Director, Regulatory Affairs  

Employer:
Simcere of America Inc.

Description:

  • Manage US Regulatory Affairs activities to develop and implement regulatory strategies for ANDA, 505b(2) and/or IND applications.

  • Provide guidance to product development and regulatory team members in China regarding US FDA requirements and assure successful completion of regulatory affairs activities.

  • Provide input for regulatory affairs requirements and regulatory affairs strategies in cross-functional meetings on product development to ensure timely submission.

  • Review and make final determinations for regulatory affairs assessments of proposed CMC changes

  • Responsible for reviewing, revising, performing gap analysis and ensuring completeness and accuracy of the content of US regulatory affairs submissions.

  • Manage, plan, compile, review and submit all regulatory affairs dossiers in a timely manner.

  • Direct communications and interactions with FDA and other regulatory affairs agencies worldwide as applicable.

 



Qualifications/Experience:

 

  • 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.

  • Experience in Oral Solid Dosage form, small molecule ANDA products. Experience in injectable is a plus

  • Hands on experience in pre-approval and post-approval process

  • Knowledge of drug product development, manufacturing process, and lifecycle management.

  • 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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