A pharmaceutical manufacturing company in Rancho Cucamonga, California is looking for the talents of an on-site Regulatory Affairs Associate to support the RA Department in ensuring compliance with industry standards and FDA requirements for all Amphastar facilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
- Assists with preparing and maintaining pre-and post-approval filings for all (A)NDAs, BLAs/Biosimilars, INDs and DMFs in accordance with FDA requirements.
- Compiles and prepares annual reports for DMFs and INDs.
- Assists with maintaining regulatory applications to support compliance with regulatory requirements.
- Prepares establishment, drug and device listings.
- Prepares submissions, amendments and supplements.
- Assists with review of regulatory submissions, as necessary.
- Collects information needed for submissions.
- Maintains tracking systems to ensure department organization.
- Ability to manage multiple projects, prioritize competing deadlines, and work independently.
- The RA Associate works at a desk in an office and does not perform laboratory tests or procedures.
EDUCATION AND EXPERIENCE:
Bachelor's degree from a four-year college or university is required. Bachelor of Science/Bachelor of Arts in a scientific discipline is required. Previous experience working in a laboratory, pharmacy or regulated industry required.
LANGUAGE AND WRITING SKILLS:
Ability to read, analyze and interpret complex documents; write and comprehend instructions; and draft correspondences and memos. Must possess the ability to effectively present information in one-on-one and small group situations. Must have good written language skills and great attention to detail.
SPECIAL REQUIREMENTS:
A thorough knowledge of personal computers is required. Experience using Adobe Acrobat, Word and/or Microsoft Office products is required. Good typing ability is required. Must be able to obtain security clearance. Occasional travel may be required.
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 number 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 federal, 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.
Job Type: Full-time
Pay: $26.40 - $32.80 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
Education:
Work Location: In person
