Regulatory Affairs Jobs

Regional Regulatory Affairs Senior Associate

**HOW MIGHT YOU DEFY IMAGINATION?** **The Amgen Capability Center in Lisbon, Portugal (ACCP)** will be home to over 300 multi-national and multi-cultural employees, representing a broad range of cross functional capabilities, including Commercial, General and Administrative, Research and Development and more. The ACCP will offer rich career growth and development opportunities, regional and global exposure […]

Manager, Regulatory Affairs and Compliance

Manager, Regulatory Affairs and Compliance Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We’re looking for innovative, forward-thinking individuals […]

Regulatory Affairs Associate Manager (CW)

– Collaborate with Clinical Operations team to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements. – Plans, reviews and recommends the best regulatory strategy for submission, including regulatory timeline. Manage and ensures that the regulatory plans are alignment with launch strategies. – Achieve timely and successful product […]

Regulatory Affairs Senior Manager CMC

**Why Patients Need You** We’re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access […]

Associate, Global Regulatory Affairs

**Why Patients Need You** Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, […]

Senior Regulatory Affairs Associate, Clinical Safety and Labelling Management

**Why Patients Need You** **We’re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access […]

GCS Inspection Readiness Lead

**Why Patients Need You** Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, […]

GCS Inspection Readiness Lead

**Why Patients Need You** Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, […]

Clinical Scientist Communications Lead, Vaccines

**Role Summary** The primary purpose of the Clinical Scientist Communications Lead (CSCL) position is to provide leadership, scientific, and project management support to clinical communication projects in conjunction with the Clinical Leads, Study Clinicians, and interfacing clinical document preparation groups. The CSCL is responsible for high-level, experienced project management support on at least one clinical […]

Sr Manager Regulatory Affairs, CMC Site Sr. Manager CMC (US-Remote)

**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that […]

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