Regulatory Affairs Senior Manager – Regional Regulatory Lead
US - California - Thousand Oaks - Field/Remote
Career Category
RegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Regulatory Affairs Senior Manager – Regional Regulatory Lead
Live
What you will do
Let’s do this. Let’s change the world. The Regulatory Affairs Senior Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services. In this vital role you will achieve the desired labeling by developing and implementing US regulatory strategies.
Responsibilities:
- 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 (eg, responses to regulatory agency questions)
- Develop US regulatory strategies
- Estimate the likelihood of regulatory success based on proposed strategies and discuss with GRT and line management
- Develop regulatory risks and predictions of interactions with regulatory agencies
- Ensure regulatory product compliance for product (e.g. IMR, PMCs, pediatric and other agency commitments)
- Provide regulatory guidance on US regulatory mechanisms to optimize product development (e.g. orphan drug, fast track, early access, pediatric plan)
- Exchange regulatory information with GRT and cross-functional colleagues on an ongoing basis and provide advice 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 an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to Amgen products.
- Perform regulatory research to acquire relevant histories, precedence and other information relevant to product advancement in the US
- Under supervision evaluate and communicate impact of relevant US regulations, guidance’s, current regulatory environment, and competitor labeling
- With general supervision, serve as point of contact and develop relationships with points of contact at the FDA on specific product assignment
- Document and communicate details and outcomes of FDA interactions to GRT and relevant Sr. management
- Under general supervision, participate in core regulatory …
This job isn't fresh anymore!
Search Fresh JobsJob Profile
Field/Remote
Benefits/PerksAnnual bonus program Career development Career development opportunities Comprehensive employee benefits Comprehensive employee benefits package Discretionary annual bonus Financial plans Flexible Spending Accounts Flexible work models Health and welfare plans Life and Disability insurance Professional and personal growth Remote work Retirement and Savings Plan Stock-based long-term incentives Time-off plans Total Rewards Plan Welfare plans
Tasks- Communication
- Develop regulatory strategies
- Develop relationships
- Ensure regulatory compliance
- Provide regulatory guidance
Biotechnology Clinical trials Communication Compliance Drug Development FDA Insurance Labeling Management Marketing Pharmaceutical Pharmaceutical Development Product Development Regulatory Affairs Regulatory Compliance Regulatory Documents Regulatory Guidance Regulatory Research Regulatory strategy Regulatory Submissions Research Risk Assessment Sales SOPS Strategy Teamwork
Experience2 years
EducationAssociate Degree DO Doctorate Doctorate degree GED High School High school diploma Master's
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9