Sr. Associate Regulatory Affairs
3 weeks ago
Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.
Responsibilities:
- Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).
- Provide and maintain CTA/MA documentation support (e.g. Annual reports, amendments) in collaboration with the Site Regulatory Lead.
- Appropriately archive all regulatory documents and agency communications, as applicable.
- Ensure compliance with submissions to regulatory agencies as assigned by the Site Regulatory Affairs representative.
- Coordinate collection of functional documents in support of regulatory applications
- Monitor completion of Country Specific Document request by other Site functional areas
- Support the preparation of regulatory documents and packages. Provide regulatory support to Commercial Operations, Process Development's New Product Introduction, and/or functional groups through cross-functional interactions within CMC.
- Respond to specific requests from and communicate relevant issues to Site RA CMC management.
- Support global registration and life-cycle management for Amgen products/site.
- Works cross functionally with local and global operations and regulatory personnel to coordinate preparation of regulatory filings and other documents used for registration purposes including: New marketing applications; Facility Registration documents; Country Submission Document (“CSD”) Requests.
Requirements
- Master degree or Bachelor degree and 2 years of related experience in a pharmaceutical industry environment or Associate’s degree and 6 years of experience in a pharmaceutical industry environment or High school diploma / GED and 8 years of experience in a pharmaceutical industry environment.
- Educational background in Biotechnology, Microbiology or Chemistry is preferred
Basic navigation skills on Microsoft Office (Word, Excel, Teams, Outlook) and Webex. - Experience in manufacturing, quality, or distribution in the Pharmaceutical/Biotech industry.
- Strong oral and written communication skills in English and Spanish
Proficiency working with teams at different levels
Able to operate in a fast paced, dynamic environment.
Requirements
Master degree or Bachelor degree and 2 years of related experience in a pharmaceutical industry environment or Associate’s degree and 6 years of experience in a pharmaceutical industry environment or High school diploma / GED and 8 years of experience in a pharmaceutical industry environment. Educational background in Biotechnology, Microbiology or Chemistry is preferred Basic navigation skills on Microsoft Office (Word, Excel, Teams, Outlook) and Webex. Experience in manufacturing, quality, or distribution in the Pharmaceutical/Biotech industry. Strong oral and written communication skills in English and Spanish Proficiency working with teams at different levels Able to operate in a fast paced, dynamic environment.
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