U.S. Regulatory Affairs Senior Manager

Career Category

Job Description

Regulatory Job Description

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 reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Regulatory Affairs Senior Manager – Regional Regulatory Lead - Oncology

Live

What you will do

Let’s do this. Let’s change the world. The Regulatory Affairs Senior Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services. In this vital role you will achieve the desired labeling by developing and implementing US regulatory strategies.

Responsibilities:

• Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US

• Provide content for and coordinate US regulatory documents and meetings in accordance with GRT strategy (eg, responses to regulatory agency questions)

• Develop US regulatory strategies

• Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line management

• Develop regulatory risks and predictions of interactions with regulatory agencies

• Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)

• Provide regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan)

• Exchange regulatory information with GRT and cross-functional colleagues on an ongoing basis and provide advice on regional considerations

• Communicate and ensure alignment of regional management before GRT strategy decisions Partner with regional management and peers to ensure consistency in procedures and agency interactions

• Partner with regional management and peers to ensure consistency in procedures and agency interactions

• Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.

• Perform regulatory research to acquire relevant histories, precedence and other information relevant to product advancement in the US

• Under supervision evaluate and communicate impact of relevant US regulations, guidance’s, current regulatory environment, and competitor labeling

• With general supervision, serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment

• Document and communicate details and outcomes of FDA interactions to GRT and relevant Sr. management

• Under general supervision, participate in core regulatory activities to ensure effective FDA interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment

• Manage the development of the US product label by collaborating with the Labeling Working Group in the context of available and expected scientific data, regulatory guidance and precedent, support label negotiations

• Consults with and supports promotion group regarding applicability of data for product communication in the US

• Keep regulatory intelligence tool(s) current

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development

Or

Master’s degree and 4 years of experience in regulatory or pharmaceutical drug development

Or

Bachelor’s degree and 6 years of experience in regulatory or pharmaceutical drug development

Or

Associate’s degree and 10 years of experience in regulatory or pharmaceutical drug development

Or

High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug development

Preferred Qualifications:

• Regulatory submissions experience (eg, INDs or CTAs)

• Experience interacting with regulatory agencies

• Knowledge of regulatory principles