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.
- Special Knowledge, Skill and Ability Requirements:
- MS office proficiency
- Strong typing skills
- Excellent verbal and written skills
- Education or Equivalent Experience:
- AA degree
- At Carlsbad Tech, 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.
- Salary range for this entry level position is $15 ~ $18 per hour depending on applicant’s working experience.
To apply for this position, please send resume to email@example.com.