Regulatory Affairs Assistant (Entry Level)
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:
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].
Recommended Jobs
Principal Software Engineer - Pay Group Engineering
About Gusto At Gusto, we're on a mission to grow the small business economy. We handle the hard stuff — payroll, health insurance, 401(k)s, and HR — so owners can focus on their craft and their …
Program/Project Analyst
For over 16 years, Trilyon has been at the forefront of providing comprehensive global workforce solutions and staffing services. Leveraging our extensive expertise across multiple domains such as Cl…
Battery Integration Principal Engineer
We are looking for an addition to our Product Development team to be responsible for the following areas: Compliance, Certification & Documentation (~40%) • Lead battery certification and compli…
04 - Chemical Processor 3
Req ID: 121322 Region: Americas Country: USA State/Province: California City: San Jose General Overview Functional Area: Operations (OPS) Career Stream: Operations Support (SUP) Rol…
Travel Nurse RN - Wound/Ostomy in California
Registered Nurse (RN) | Wound/Ostomy Location: California Agency: job.com Pay: Competitive weekly pay (inquire for details) Shift Information: 5 days x 8 hours Start Date: ASA…
Carson: warehouse general labor worker
We are seeking candidates interested in fast-paced working environments. This warehouse job assignment can be either short-term or long-term, depending on warehouse needs. Requirements: ALL AROU…
Senior Sales Representative
At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash thei…
Investment Banking - Mid - Cap Investment Banking
We are seeking a highly skilled and experienced Analyst to join our dynamic Mid-Cap Investment Banking team, offering an exceptional opportunity to contribute to high-profile transactions and drive g…
Quality Inspector
Build your strengths here 100,000 products and tools made from the strong metals tungsten and molybdenum: this has been our mission and our passion for over 100 years, which is shared by our 11,000 e…