Regulatory Affairs Manager – US Regulatory Lead, Rare Disease

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist the Global Regulatory Team with US Regulatory Activities, including the development and submission of INDs.

• Serve as the main contact for regulatory agencies.

• Offer advice on local mechanisms to enhance product development and secure regulatory approvals.

• Organize and oversee local regulatory submissions in accordance with corporate standards and local regulatory requirements.

• Ensure compliance of local regulatory products, including commitments to agencies.

• Create and update local labels in alignment with local laws and Amgen's standards and procedures.

• Contribute to and inform the global regulatory strategy for assigned products, including Global Regulatory Plans and labeling documents.

• Prepare supporting documentation for regulatory deliverables, such as regulatory landscapes or research for regulatory strategy and target product labels.

• Oversee the process for addressing inquiries from regulatory agencies.

• Provide primary authorship for routine regulatory correspondence.

• Collaborate with federal, state, and local regulatory agencies regarding issues and regulations impacting Amgen’s products and services.

⛳️ Requirements

• Doctorate degree, OR a Master’s degree with 2 years of experience in Regulatory Affairs, OR a Bachelor’s degree with 4 years of experience in Regulatory Affairs, OR an Associate's degree with 8 years of experience in Regulatory Affairs, OR a high school diploma/GED with 10 years of experience in Regulatory Affairs.

• Master’s degree in a biology, life science, health science curriculum, or regulatory science with a biology curriculum.

• Experience in a regulated industry, science, or clinical practice.

• Strong organizational skills; attentive to detail and adaptable to frequent changes in product activity.

🏝️ Benefits

• A comprehensive employee benefits package.

• Retirement and Savings Plan featuring generous contributions from the company.

• Group medical, dental, and vision insurance 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 feasible.

• Opportunities for career development.

• Support for work/life balance.

• Financial plans with options to save for retirement or other goals.