Global Regulatory Affairs Director – Inflammation and Rare Disease

🔥 16 minutes ago

🇺🇸 United States – Remote

💵 $189.6k - $256.6k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Develop and execute the global regulatory product strategy • Lead Global Regulatory Teams (GRTs) • Represent Regulatory on the product team and key commercialization governance bodies • Develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan • Identify and communicate regulatory risks • Develop registration strategies and plans for regulatory approval and product labeling • Provide regulatory direction in development of the core data sheet • Lead planning and implementation of global regulatory filings, including clinical trial applications, marketing applications, label extensions, and CMC changes • Ensure consistency of evidence-based global product communication and regulatory submission documents • Monitor and assess relevant global regulations, guidance, and the regulatory environment • Assess and incorporate regulatory mechanisms such as FIH studies, Orphan Drug, Fast Track, conditional/accelerated approval, compassionate use, and pediatric plans • Communicate regulatory strategies throughout the organization • Lead core regulatory and cross-functional teams for effective regulatory agency communications • Attend key regulatory agency meetings affecting global product strategy • Represent Amgen Regulatory on external partnership teams at the product level

🎯 Requirements

• Doctorate degree and 4 years of regulatory experience in biotech or science • Or Master’s degree and 7 years of regulatory experience in biotech or science • Or Bachelor’s degree and 9 years of regulatory experience in biotech or science • 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 • Negotiation skills

🏖️ Benefits

• A 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 • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance