Sr Associate Regulatory Writing

Career Category Regulatory The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company s products meet and maintain regulatory standards They assist in preparing submissions for regulatory agencies keep updated on changes in regulatory legislation and guide various teams within the company to ensure...

The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams toOptimize product development and regulatory approvals in International countriesDevelop...

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable...

Roles & Responsibilities:Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional teamEnsure consistent quality across documents, ensure submission readiness, and...

ABOUT AMGENAmgen 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...

Senior Manager, Global Regulatory Writing Career CategoryRegulatory Job Description At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's...

Sr. Associate Regulatory Affairs Career CategoryRegulatory Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of...

What you will doIn this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standardsWrite or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4)Write CTD sections including the Summary of...

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgens CMC submission execution team, Regulatory...

Sr Manager - Gen Med Biosims International Regulatory LeadThe Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements.Group PurposeInternational Regulatory Affairs provides...