Specialist/Senior Specialist of Regulatory Affairs

Responsibility

1. 01

   Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations

2. 02

   Lead the preparation of CMC regulatory submissions namely INDs/BLAs applications including scientific and technical review for accuracy, soundness and regulatory appropriateness

3. 03

   Ensure timely preparation and management of all necessary documentation for regulatory submissions

4. 04

   Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines

5. 05

   The candidate is expected to maintain up-to-date knowledge and expertise of relevant ICH guidelines, CFDA, FDA, and EMA regulations

6. 06

   Represents WuXi Biologics in interactions with Regulatory Agencies and clients’ RA CMC representatives.

1. 01

   Minimum BS degree in one of the relevant life sciences is desirable. Advanced degree and RAC certification are pluses.

2. 02

   BS degree with 3+ years experience ；MS degree with 1+ years experience.

3. 03

   The candidate must demonstrate solid working knowledge of biologics development processes.

4. 04

   Thorough understanding of FDA and EMA regulatory requirements and GMP regulation is required.

5. 05

   The candidate must be detail oriented with strong project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral).

6. 06

   Experience with AI tools, including development and practical application, is a plus.