US Regulatory Affairs Manager (US-REMOTE)

Company: Initial Therapeutics, Inc.
Location: Washington
Posted on: April 21, 2025

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.US Regulatory Affairs ManagerWhat you will doLet's do this. Let's change the world. Amgen is searching for a Regulatory Affairs Manager to work in our Global Regulatory Affairs group. This Manager will report to the Senior Director Regulatory Affairs and will work remotely with as needed work out of our campus in Thousand Oaks, CA. In this vital role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team (GRT), the Manager will achieve the desired labeling by developing and implementing regional regulatory strategies and managing effective agency interactions. Responsibilities for the Regulatory Affairs Manager include:

• Ensure that Amgen acquires and maintains all the licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
• Ensure regulatory compliance, with a focus on patient safety.
• Implement the approved regional strategy for assigned programs.
• Consult with the Global Regulatory Team (GRT) on regional considerations in developing strategy.
• Ensure the regional needs are well defined and implemented in collaboration with relevant regional partners.
• Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements.
• Under supervision, implement product related regulatory strategies, Regulatory Affairs processes and activity planning in alignment with national legislation and regulatory requirements.
• Provide content guidance for regional regulatory documents and meetings in accordance with GRT strategy.
• Provide regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conscientious use and pediatric plan).
• Manage the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
• Support regional label negotiation activities.
• Under general supervision participate in the development, and implementation of regional regulatory product strategies, including precedence, risk management and contingency planning.
• Consistent with GRT strategy, coordinate with team on regulatory implications and requirements related to global clinical development plans and objectives.
• Obtain and maintain Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs).
• Communicate regulatory strategies within team (e.g. GRT, local affiliates).
• Under general supervision, develop predictions for expectations and risks associated with outcomes by regulatory agencies.
• Ensure regulatory product compliance for product (e.g. PMCs, pediatric and other agency commitments).
• 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 obtain relevant histories, precedence and other information relevant to regional product advancement.What we expect of youWe 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 DegreeORMaster's Degree & 3 years of Regulatory experienceORBachelor's Degree & 5 years of Regulatory experienceORAssociate's degree & 10 years of Regulatory experienceORHigh school diploma/GED & 12 years of Regulatory experiencePreferred Qualifications:
  • Regulatory submissions experience
  • Experience interacting with regulatory agencies
  • Clinical Development experience
  • Cross-functional experience
  • 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
  • Communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Ability to anticipate and prevent potential issues
  • 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 outcomeWhat you can expect of usAs 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 annual base salary range for this opportunity in the U.S. is $105,663 - $130,334.In addition to the base salary, 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 nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com
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Keywords: Initial Therapeutics, Inc., Baltimore , US Regulatory Affairs Manager (US-REMOTE), Executive , Washington, Maryland