Regulatory Affairs Director – Global Regulatory Leader, Rare Disease

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $189.6k - $256.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan • Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling • Provides 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 • Leads development, review and approval of the target product label (TPL) • Obtains input from the GRT members (e.g. RRLs, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance • Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes) • Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents) • Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions • Monitors and assess impact of relevant global regulations, guidances, and current regulatory environment • Ensures guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy • Consistently communicates well defined, successful regulatory strategies throughout the organization such that expectation is understood • Produces strategies that provide innovative alternatives which communicate the associated risks • Communicates Amgen’s position consistently cross-functionally and across all documents • Develops the ability to articulate and educate the likelihood of regulatory success based on proposed strategies • Develops ability to accurately predict expectations and outcomes by regulatory agencies • Directs global regulatory agency interaction strategies, in collaboration with regional colleagues • Ensures effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams) • Ensures consistent communication of product information to Health Authorities • Attends key regulatory agency meetings which could impact the global product strategy • Leads GRT to develop and execute team goals • Provides coaching and mentoring to GRT members • Integrates regional regulatory representative input into GRT and regulatory plans • Communicates and ensures alignment of global functional and cross-functional goals and objectives • Represents Global Regulatory Affairs on key commercialization teams (e.g, PT, EGT, GST) • Represents Amgen GRA on external partnership teams at the PT level • Provides education and training on regulatory strategies and compliance issues to other PT functions • Ensures regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments) • Advocates for Amgen/GRAAS by building strong relationships with key external stakeholders including senior regulatory agencies, trade associations, and influential professional bodies • Works externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area • Develop regulatory due diligence assessment of licensing/acquisition opportunities as assigned by management.

🎯 Requirements

• Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience • At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • Demonstrated ability to lead teams • Strong communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Understanding of regulatory activities and how they affect projects and processes • Ability to anticipate and mitigate against future strategic issues & uncertainties • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome – influencing and negotiation skills • Cultural awareness and sensitivity to achieve results across both regional country and International borders.

🏖️ 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.