Regulatory Affairs Specialist

2 days ago


San Diego, California, United States Ajinomoto Bio-Pharma Full time
Regulatory Affairs Specialist

Ajinomoto Bio-Pharma is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for providing support for all internal and external regulatory-related activities.

Key Responsibilities:

  • Collaborate with internal team members to maintain compliance with regulatory requirements
  • Identify relevant guidance documents and provide interpretive analysis
  • Communicate with regulatory agencies regarding pre-submission strategies and compliance test requirements
  • Prepare submissions of license applications and renewals
  • Track and maintain licenses and company submissions

Requirements:

  • Bachelor's degree in a Life Sciences discipline or equivalent
  • Minimum of 4-6 years of experience in regulatory affairs, QA, or equivalent
  • Familiarity with cGMP regulations and good documentation practices

Ajinomoto Bio-Pharma offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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