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Location

Carlsbad, CA | United States

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Job description

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):

1. 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.
2. To assist Department Head in contact with local, state, and federal regulatory agencies.
3. 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.
4. To assist in coordinating with labeling revision and review, and hence revise the standard operating procedures (SOP).
5. To assist in customer inquiry and customer complaint and MedWatch reports.
6. To assist in preparing Annual Report, Adverse Drug Event report and other regulatory documents such as CBE-30.
7. To maintain and renew waste water, air pollution, controlled substance or other license with the local government departments.
8. Other administrative duties such as revising SOPs, as assigned.

Minimum Requirements:

1. Special Knowledge, Skill and Ability Requirements:

MS office proficiency

Strong typing skills

Excellent verbal and written skills

1. Education or Equivalent Experience:

AA degree

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 [email protected].

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Job tags

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Salary