Regulatory Affairs Assistant

1 week ago

Carlsbad, United States Carlsbad Tech Full time

Regulatory Affairs Assistant (Entry Level) job at Carlsbad Tech . Carlsbad, CA. Basic Function Perform a variety of responsible, confidential and administrative duties in assisting Department Heads for compliance with local, state, and federal regulations. Work Performed (In Order of Importance) To apply, maintain and renew all 50 States wholesale distributor licenses/permits for the facilities and provide administrative and secretarial support for the Regulatory Affairs Dept. To assist Department Head in contact with local, state, and federal regulatory agencies. To assist in establishing and maintaining the required documentation for facility registration, technical report, drug listing, drug application, amendment/supplement submission, drug registration, and other filing activities to the FDA. To assist in coordinating with labeling revision and review, and hence revise the standard operating procedures (SOP). To assist in customer inquiry and customer complaint and MedWatch reports. To assist in preparing Annual Report, Adverse Drug Event report and other regulatory documents such as CBE-30. To maintain and renew waste water, air pollution, controlled substance or other license with the local government departments. Other administrative duties such as revising SOPs, as assigned. Minimum Requirements Special Knowledge, Skill and Ability Requirements MS office proficiency Strong typing skills Excellent verbal and written skills Education or Equivalent Experience AAdegree Compensation At Carlsbad Technology Inc, every eligible employee receives a competitive compensation package including Medical, Dental, Vision, Life Insurance, Short Term Disability, and Company match on 401K. Employees are also entitled to Paid Time Off, Sick Days, and Holidays. To apply for this position, please send resume to #J-18808-Ljbffr

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