Senior Associate, Nonclinical Regulatory Specialist

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🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $101.7k - $137.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Partner with nonclinical scientists, functional area representatives, and regulatory stakeholders to coordinate nonclinical regulatory planning, document development, and regulatory readiness • Develop, maintain, and communicate integrated timelines for nonclinical regulatory documents and deliverables • Coordinate cross-functional activities and facilitate delivery of nonclinical regulatory packages • Facilitate planning meetings, document decisions, track action items, and follow up on commitments • Monitor progress, identify risks or delays, communicate issues, and support mitigation plans • Serve as the day-to-day operational partner for assigned product teams • Build collaborative relationships across scientific, regulatory, and operational functions • Support standard operating procedures, templates, job aids, and operational guidance documents • Identify opportunities to improve planning, coordination, communication, and operational efficiency • Participate in continuous improvement initiatives and contribute to knowledge sharing and departmental initiatives

🎯 Requirements

• Master’s degree and 1 year of directly related experience, or Bachelor’s degree and 5 years of directly related experience, or Associate’s degree and 10 years of directly related experience • Directly related experience in pharmaceutical research and development, nonclinical sciences, regulatory affairs, scientific operations, program or project management, or related life sciences, biotech, or pharmaceutical disciplines • Experience supporting pharmaceutical research and development or nonclinical drug development programs • Understanding of nonclinical drug development, regulatory requirements, and nonclinical data and documentation in global regulatory submissions • Experience coordinating complex, cross-functional programs • Project or program management skills, including timeline development, milestone tracking, risk management, and meeting facilitation • Ability to build collaborative relationships and influence cross-functional teams without direct authority • Strong organizational skills and ability to manage multiple priorities • Excellent written, verbal, and interpersonal communication skills • Experience coordinating scientific or regulatory documents throughout the document lifecycle • Ability to improve operational processes, preferably using AI/ML applications • Experience with document management systems, collaboration platforms, and project management tools • Experience with digital technologies, automation tools, or AI-enabled solutions is desirable • Familiarity with Good Laboratory Practice (GLP), Good Documentation Practices (GDP), and global regulatory expectations • Bachelor’s or advanced degree in a life science discipline, regulatory affairs, business, or related field is preferred • Sponsorship for this role is not guaranteed

🏖️ Benefits

• Comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Collaborative culture supporting professional and personal growth and well-being