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Shan Huang MS (RA), RAC

Shan Huang MS (RA), RAC

Senior Manager Regulatory Affairs CMC at Seqirus

Wayland, Massachusetts

• Regulatory Affairs Certification (RAC) (US) from RAPS
• M.S. in regulatory affairs for drugs, biologics, and medical devices.
• Good understanding of ICH and FDA guidelines relevant to CMC aspects of product development and maintenance
• Extensive training and hands-on experiences in the regulatory affairs of drugs, biologics, and medical devices.
• Diligent in paying attention to details and multitasking to deliver high quality results in time sensitive environments.
• Proven track record of providing satisfactory service to clients with clear communication, good turnaround time and flexibility in adapting unexpected changes.


Skill Highlights:
• A detailed understanding of the submission processes in biologic and small molecule new drug development.
• Good understanding of related laws, regulations, and guidelines.
• Good grasp of principles to work with FDA.
• Familiar with regulatory requirement in the process of drug and medical device development in accordance with GCP, GMP, GLP etc.
• Excellent writing and presentation skills.
• Proficient in software (advanced MS Word, Excel, PowerPoint, and Adobe Acrobat Professional).


Experience:

  • Senior Manager Regulatory Affairs CMC (Seqirus)
  • Manager Regulatory Affairs CMC (Takeda)
  • Manager Regulatory Affairs CMC (Shire)
  • Sr. Regulatory Affairs Specialist (Syner-G Pharma CMC Consulting, LLC)
  • Sr. Associate Scientist (AstraZeneca)

Skills:

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