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Regulary Affairs Assistant or Associate Director (Shanghai/Wuxi, China)

Key Accountibilities:

  • Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations
  • Support the preparation of CMC regulatory submissions namely INDs/BLAs applications including scientific and technical review for accuracy, soundness and regulatory appropriateness
  • Ensure timely preparation and management of all necessary documentation for regulatory submissions
  • Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines
  • The candidate is expected to maintain up-to-date knowledge and expertise of relevant ICH guidelines, CFDA, FDA, and EMA regulations
  • Responsible for establishing and maintaining internal filing template and ensure submission quality and consistency
  • Represents WuXi Biologics in interactions with Regulatory Agencies and clients’ RA CMC representatives.
  • Requirements:

  • The candidate must demonstrate solid working knowledge of biologics development processes.
  • Thorough understanding of FDA and EMA regulatory requirements and GMP regulation is required
  • The candidate must be detail oriented with li project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral).
  • The candidate must have expertise in Chinese FDA regulations and experience interacting with CFDA. The candidate must be fluent in Chinese both written and oral
  • Minimum BS degree in one of the relevant life sciences is desirable. Advanced degree and RAC certification are pluses.