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Summary:
- We are looking to hire a Regulatory Affairs Generalist/Specialist. The selected applicant will ensure compliance with state and federal pharmacy licensing requirements, annual and quarterly safety report requirements, maintain regulatory files and assists in preparation of regulatory submissions. Experience is not required. At a minimum, interested applicants must have an Associates Degree.
*******Job Description Below*********
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Prepares original and renewal applications for state board of pharmacy licenses, as associated paperwork.
- Compiles and prepares annual reports and quarterly safety reports for all IMS (A)NDA filings.
- Prepares annual drug and device listings and maintains annual registration documents.
- Assists in preparing supplemental (A)NDA filings.
- Performs other general office clerical duties as required.
Useful Skills:
- Proficient use of Microsoft Office and Adobe PDF.
- Attention to Detail
- Strong writing skills
Location:
- South El Monte, California
- We do not offer relocation expenses.
- Preferably the candidate resides in California.
Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Sunshine Act
Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.
EEO & Employment Eligibility
Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer.
Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Work Remotely
Job Type: Full-time
Pay: $25.40 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
Schedule:
- 8 hour shift
- Holidays
- Monday to Friday
- Overtime
- Weekends as needed
Education:
Work Location: In person