Senior Regulatory Affairs Manager – Regional Regulatory Lead

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $142.6k - $192.9k / year

⏰ Full Time

🟠 Senior

🚔 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

• Achieve desired labeling by developing and executing US regulatory strategies within the obesity and metabolic disease therapeutic area • Execute the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US • Provide content for and coordinate US regulatory documents and meetings in accordance with GRT strategy • Develop US regulatory strategies and assess likelihood of regulatory success • Develop regulatory risks and predictions of interactions with regulatory agencies • Ensure regulatory product compliance, including IMR, PMCs, pediatric, and other agency commitments • Provide regulatory guidance on US mechanisms such as orphan drug, fast track, early access, and pediatric plans • Exchange regulatory information with GRT and cross-functional colleagues and advise on regional considerations • Communicate and ensure alignment of regional management before GRT strategy decisions • Partner with regional management and peers to ensure consistency in procedures and agency interactions • Maintain awareness of legislation, regulatory policy, and technical guidance relating to Amgen products • Perform regulatory research on histories, precedents, and other information relevant to product advancement in the US • Evaluate and communicate the impact of US regulations, guidance, regulatory environment, and competitor labeling • Serve as a point of contact and develop relationships with FDA contacts for assigned products • Document and communicate FDA interaction details and outcomes to GRT and senior management • Participate in core regulatory activities and contingency regulatory planning/risk assessment • Manage US product label development with the Labeling Working Group and support label negotiations • Advise and support the promotion group regarding US product communication data • Keep regulatory intelligence tools current

🎯 Requirements

• Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development; or Master’s degree and 4 years of experience; or Bachelor’s degree and 6 years of experience; or Associate’s degree and 10 years of experience; or high school diploma/GED and 12 years of experience • Experience in cardiometabolic therapeutic area highly preferred • Regulatory submissions experience, such as INDs or CTAs • Experience interacting with regulatory agencies • Knowledge of regulatory principles • Experience working with policies, procedures, and SOPs • Knowledge of national legislation and regulations relating to medicinal products • Awareness of registration procedures for marketing applications, post-approval changes, extensions, and renewals • Knowledge of drug development • Teamwork • Oral and written communication skills • Ability to understand and communicate scientific/clinical information • Knowledge of and experience in the regional regulatory environment in the relevant product area and development stage • Understanding of regulatory activities and their touch points • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome • Cultural awareness and sensitivity across regional, country, and international borders • Sponsorship for this role is not guaranteed

🏖️ 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 • 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 • Financial plans with opportunities to save towards retirement or other goals

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