Regulatory Affairs Senior Manager - Regional Regulatory Lead
November 26
🇺🇸 United States – Remote
💵 $139.7k - $166.4k / year
⏰ Full Time
🟠 Senior
🚔 Compliance
🦅 H1B Visa Sponsor
Description
• The Regulatory Affairs Senior Manager at Amgen ensures compliance with regulations and laws. • Collaborate with federal, state, and local regulatory agencies on product and service regulations. • Develop and implement US regulatory strategies for label approvals.
Requirements
• Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development • Master’s degree and 4 years of experience in regulatory or pharmaceutical drug development • Bachelor’s degree and 6 years of experience in regulatory or pharmaceutical drug development • Associate’s degree and 10 years of experience in regulatory or pharmaceutical drug development • High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug development • 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
Benefits
• Comprehensive employee benefits package, • Retirement and Savings Plan with generous company contributions, • Group medical, dental and vision coverage, • Life and disability insurance, • Flexible spending accounts. • Discretionary annual bonus program, • Stock-based long-term incentives, • Award-winning time-off plans and bi-annual company-wide shutdowns, • Flexible work models, including remote work arrangements.
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