Global Regulatory Affairs Director – Inflammation and Rare Disease

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $189.6k - $256.6k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $28.5G Post-IPO Debt on 2022-12

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.

📋 Description

• Develop and execute the global regulatory product strategy • Lead GRTs • Represent Regulatory on the product team and other key commercialization governance bodies • Develop Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. • Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. • Identify and communicate regulatory risks • Represent GRA on the product team • Develop registration strategies and plans aimed at achieving regulatory approval and product labeling • Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent • Lead the planning and implementation of global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes) • Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents) • Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment • Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) is assessed and incorporated into the global regulatory strategy • Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood • Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams) • Attend key regulatory agency meetings which could impact the 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, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.