Regulatory Affairs Director - Oncology
November 4
🇺🇸 United States – Remote
💵 $188.6k - $218.5k / year
⏰ Full Time
🔴 Lead
🚔 Compliance
🦅 H1B Visa Sponsor
Description
• To lead a team within Amgen’s Global Regulatory Affairs department • To develop a comprehensive regulatory strategy • To provide regulatory expertise and guidance to product teams • Develop and execute the global regulatory product strategy • Lead Global Regulatory Teams • Represent Global Regulatory Affairs on the Product Team and key commercialization governance bodies • Develop Global Regulatory Strategic Plans • Identify and communicate regulatory risks • Ensure consistency of evidence-based global product communication • Monitor and assess impact of relevant global regulations
Requirements
• Doctorate degree and 4 years of regulatory experience in biotech or science , OR Master’s degree and 8 years of regulatory experience in biotech or science, OR Bachelor’s degree and 10 years of regulatory experience in biotech or science • Contemporary oncology experience desired • Ability to lead and build effective teams • Strong communication skills – both oral and written • Ability to understand and communicate scientific/clinical information • Ability to anticipate and mitigate against future strategic issues & uncertainties • Ability to resolve conflicts and develop a course of action • Cultural awareness and sensitivity to achieve global results • Planning and organizing abilities • Able to prioritize and manage multiple activities • Ability to make complex decisions and solve problems • Ability to deal with ambiguity • Organizational savvy • Negotiation skills
Benefits
• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A 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, where possible
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