Regulatory Affairs, Senior Associate
1 month ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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, Senior AssociateLive
What you will do
Lets do this. Lets change the world. In this vital role you will support Non-Clinical Submission Management activities related to scientific study report writing and nonclinical contributions to regulatory submissions.Key Activities:Planning and strategic support for Research and GRAAS (Global Regulatory Affairs and Strategy)Contributing to overall submission of nonclinical content, planning of timelines for authoring, reviews (QA-QC and management workflows) and hand-offSupport for research staff with comprehensive guidance on writing nonclinical documents for regulatory submissions (Modules 2.4, 2.6, and 4) and generating customized (nonclinical) project management plans for pipeline programs (pre-PT to post-market)Provide QC, secondary authoring support and coordinating review workflows services for study reports and nonclinical documentsParticipate in PT-enabling discussions (e.g. nonclinical LO and PT strategy meetings) and functional workstreamWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications. Basic Qualifications: Masters degree Or Bachelors degree and 2 years of experience within the pharmaceutical, biotech or medical device industry, including quality, compliance-related experience and/or nonclinical research. Or Associates degree and 6 years of experience within the pharmaceutical, biotech or medical device industry, including quality, compliance-related experience and/or nonclinical research. Or High school diploma / GED and 8 years of experience within the pharmaceutical, biotech or medical device industry, including quality, compliance-related experience and/or nonclinical research. ThriveWhat you can expect of us As 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Amgen 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.
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