Senior Director, Global Regulatory Affairs – Obesity

November 21

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Amgen

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Biotechnology • Pharmaceuticals • Science

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.

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

📋 Description

• Support products in the Obesity Therapeutic Area • Provide Regulatory leadership to cross-functional teams for high complexity programs • Independently develop a comprehensive regulatory strategy for one or more high complexity programs • Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets • Represent GRA on the product team and other key commercialization governance bodies • Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan • Identify and communicate regulatory risks • Lead the planning and implementation of global regulatory filings • Monitor and assess the impact of relevant global regulations • Ensure consistency of evidence-based global product communication • Clearly and succinctly communicate regulatory strategies and associated risks to the organization • Lead GRTs and product teams in formal and informal communications with regulatory agencies

🎯 Requirements

• Doctorate degree and 5 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 obesity 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 communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Ability to anticipate and mitigate against future strategic issues and 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, 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