Senior Director – Global Regulatory Affairs, Oncology

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $215.2k - $291.2k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Lead one or more Global Regulatory Teams within Global Regulatory Affairs • Develop comprehensive global regulatory strategies for high-complexity oncology programs • Drive product development, global registration, regional labeling, and regulatory agency interactions • Represent Global Regulatory Affairs on product teams and commercialization governance bodies • Develop Global Regulatory Strategic Plans and provide input to Global Strategic Plans • Identify and communicate regulatory risks, mitigations, and contingencies • Provide regulatory direction for core data sheet development • Lead planning and implementation of global regulatory filings, including clinical trial applications, marketing applications, and label extensions • Ensure consistency of evidence-based global product communications and submission documents • Monitor global regulations, guidance, and the regulatory environment and advise teams on implications • Assess regulatory mechanisms such as expedited studies, Orphan Drug Designation, Fast Track Designation, accelerated approval, compassionate use, and pediatric plans • Lead formal and informal communications and interactions with regulatory agencies • Represent Amgen Regulatory on external product-level partnership teams • Lead regulatory process improvements and initiatives

🎯 Requirements

• Doctorate degree and 5 years of regulatory experience in biotech or science, or Master’s degree and 9 years, or Bachelor’s degree and 11 years • At least 5 years of experience directly managing people and/or leading teams, projects, programs, or directing resource allocation • Contemporary oncology experience desired • Demonstrated ability to lead regulatory aspects of highly complex programs in late development • Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application • Ability to lead and build effective teams • Strong oral and written communication skills • Ability to understand and communicate scientific/clinical information • Ability to anticipate and mitigate future strategic issues and uncertainties • Ability to resolve conflicts and develop courses of action • Cultural awareness and sensitivity to achieve global results • Planning, organizing, prioritization, and multi-activity management abilities • Ability to make complex decisions and solve problems • Ability to deal with ambiguity • Organizational savvy • Negotiation skills • Sponsorship for this role is not guaranteed

🏖️ Benefits

• A 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 • Flexible work models where possible • Career development opportunities • Work/life balance support