Regulatory Affairs Specialist
2 days ago
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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