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Sr. Associate Regulatory Affairs
Amgen
posted 1d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Additional job responsibilities include:
- Lead submission for annual reports, facility registrations, facility renewals, and product renewals
- Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions
- Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications
- Coordination, preparation, collection and/or legalization of CMC country specific documents
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select CMC procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
Basic Qualifications:
- Masters degree OR
- Bachelors degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
- Associates degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
- High school diploma GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Preferred Qualifications:
- BS degree in Life Science
- Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
- Regulatory CMC specific knowledge and experience
- Mature project management and organizational skills
- Strong and effective oral and written communication skills
- Experience in Veeva Vault platforms
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
Amgen Benefits
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Health Insurance Child care Education Assistance Employee volunteer program and company matching donation program Flexible work environment Competitive base pay and annual bonus opportunities
Submitted by Employees
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