HOW MIGHT YOU DEFY IMAGINATION?You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Regulatory Affairs Manager – Regional Regulatory LeadLiveWhat you will doLet’s do this. Let’s change the world. Let’s do this. Let’s change the world. 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 activities to ensure effective FDA interactions consistent with the Global Regulatory strategy—includes contingency regulatory planning/risk assessment
Manage the development of the US product label by collaborating with the Labeling Working Group in the context of available and expected scientific data, regulatory guidance and precedent, support label negotiations
Advise and support promotion group regarding applicability of data for product communication in the US
Keep regulatory intelligence tool(s) current
WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degreeOrMaster’s degree and 2 years of experience in regulatory or pharmaceutical drug developmentOrBachelor’s degree and 4 years of experience in regulatory or pharmaceutical drug developmentOrAssociate’s degree and 8 years of experience in regulatory or pharmaceutical drug developmentOrHigh school diploma / GED and 10 years of experience in regulatory or pharmaceutical drug developmentPreferred Qualifications:
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
ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and 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
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
