US Regulatory Lead

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

📋 Description

• Develop and implement regulatory strategies for designated Amgen products within the United States.

• Ensure alignment of local regulatory requirements with Amgen's corporate standards.

• Organize and oversee regulatory submissions in accordance with both corporate and local guidelines.

• Offer advice on strategies to enhance product development and facilitate regulatory approvals.

• Create and maintain local product labeling.

• Ensure and advocate for regulatory product compliance, which includes IMR, PMCs, pediatric plans, and commitments to agencies.

• Serve as the primary contact for regulatory agencies and engage in agency discussions.

• Assist in global regulatory strategies, strategic planning, and documentation for labeling.

• Contribute to filing strategies and carry out marketing authorization and lifecycle maintenance submissions.

• Draft, review, and approve country-specific labeling source text and manage country artwork.

• Collaborate with Regional and Global Study Operations teams on the planning and execution of clinical studies.

• Review and give approval for promotional and non-promotional materials.

• Keep track of legislation, trade organizations, and the external regulatory landscape.

• Handle urgent safety communications, DHPCs, and DIL submissions.

• Provide guidance to global teams regarding local regulatory considerations.

• Supply regulatory expertise on expedited studies, Orphan Drug Designations, expedited regulatory designations, compassionate use, and pediatric plans.

• Share regulatory insights with regulatory and cross-functional teams.

• Collaborate with International and Global Regulatory Leads.

• Participate in process improvement projects and initiatives.

• Manage relationships with external vendors and contractors when necessary.

• Conduct regulatory research as needed.

• Mentor junior Local Regulatory Representatives.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 3 years of US Regulatory experience OR Bachelor’s degree with 5 years of US Regulatory experience OR Associate’s degree with 10 years of US Regulatory experience OR High school diploma/GED with 12 years of US Regulatory experience.

• Demonstrated experience in directly managing personnel and/or leadership experience in guiding teams, projects, programs, or directing resource allocation.

• Knowledge of drug development processes.

• Familiarity with regulatory principles.

• Experience with regulatory submissions and interactions with regulatory agencies (FDA).

• Solid understanding of U.S. legislation and regulations regarding medicinal products and applicable regulatory principles.

• Thorough comprehension of regulatory activities and their implications on various projects and processes.

• Relevant knowledge and experience in the U.S. regulatory environment concerning product area and development stage.

• Excellent teamwork skills.

• Strong oral and written communication abilities.

• Effective negotiation and influencing skills.

• Capability to comprehend and convey scientific and clinical information.

• Skills in conflict resolution and formulating beneficial courses of action.

• Experience in working with policies, procedures, and standard operating procedures (SOPs).

• Cultural awareness and sensitivity across regional, national, and international boundaries.

🏝️ Benefits

• A comprehensive employee benefits package.

• Retirement and Savings Plan featuring generous company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where applicable.

• Opportunities for career development.

• Support for work/life balance.