Regulatory Affairs Senior Manager – Regional Regulatory Lead

1 month ago

Washington, Washington, D.C., United States Amgen Full time

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

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
  • 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
  • Working with policies, procedures, and SOPs
  • Knowledge of national legislation and regulations relating to medicinal products
  • Awareness of the registration procedures in region for MA, post approval changes, extensions, and renewals
  • Knowledge of drug development
  • Teamwork
  • Communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Knowledge of and experience in regional regulatory environment in relevant product area and development stage
  • Understanding of regulatory activities and their touch points
  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
  • Cultural awareness and sensitivity to achieve results across both regional country and international borders

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.


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