Regulatory Affairs Senior Manager - Regional Regulatory Lead

15 hours ago

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Amgen

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Biologics • Human therapeutics • Development of novel products

10,000+

💰 Post-IPO Debt on 2022-12

Description

• The Regulatory Affairs Senior Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. • Work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services. • Achieve the desired labeling by developing and implementing US regulatory strategies. • Implement 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 estimate the likelihood of regulatory success based on proposed strategies. • Ensure regulatory product compliance for product. • Provide regulatory guidance on US regulatory mechanisms to optimize product development. • Exchange regulatory information with GRT and cross-functional colleagues on an ongoing basis. • Communicate and ensure alignment of regional management before GRT strategy decisions. • Perform regulatory research to acquire relevant histories, precedence and other information relevant to product advancement in the US. • Serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment.

Requirements

• Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development • Or Master’s degree and 4 years of experience in regulatory or pharmaceutical drug development • Or Bachelor’s degree and 6 years of experience in regulatory or pharmaceutical drug development • Or Associate’s degree and 10 years of experience in regulatory or pharmaceutical drug development • Or High school diploma / GED and 12 years of experience in regulatory or pharmaceutical drug development • Regulatory submissions experience (eg, INDs or CTAs) • Experience interacting with regulatory agencies • Knowledge of regulatory principles • Working with policies, procedures, and SOPs • Knowledge of national legislation and regulations relating to medicinal products • Awareness of the registration procedures in region for MA, post approval changes, extensions, and renewals • Knowledge of drug development • Teamwork • Communication skills - both oral and written • Ability to understand and communicate scientific/clinical information • Knowledge of and experience in regional regulatory environment in 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 to achieve results across both regional country and international borders

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