Senior Associate, Regulatory Affairs – CMC

🔥 19 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $84k - $113.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Facilitate product development and global registration by developing and executing regulatory strategies • Manage effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle • Contribute as a member of the global regulatory CMC product team • Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions • Contribute to the organization and preparation of CMC investigational product amendments, post-market supplements/variations, and new marketing applications • 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

🎯 Requirements

• Master’s degree OR Bachelor’s degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience OR Associate’s degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience OR High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or Scientific experience • BS degree in life science • Experience in manufacture, process development, quality assurance, quality control, or analytical development • Regulatory CMC specific knowledge and experience • Developed project management and organizational skills • Strong and effective oral and written communication skills.

🏖️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.