Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
Post : Sr. Associate Regulatory Affairs
Job Description
The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level.
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
Candidate Profile
• Master’s degree OR
• Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
• Associate’s 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
• 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
Additional Information
Experience : 1-2 years
Qualification : Master’s degree OR Bachelor’s degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R-203395
End Date : 20th February 2025
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