Regulatory Affairs CMC
- 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,
- 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 strong 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.
- BS degree with 8-10 years experience
- MS degree with 5-8 years experience
- PhD degree with 3-5 years experience
Primary Location: China – Shanghai
To apply please send your application to HR_Biologics@wuxiapptec.com