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Regulatory Affairs Manager

3 months ago

Albany, New York, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Regulatory Affairs Manager, CMC.

Live

What you will do

Lets do this. Lets change the world. In this vital role you will provide regulatory strategy for lifecycle management products. This position will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams, participates in site change control teams

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a leader with these qualifications.

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Provide CMC regulatory strategy for products manufactured at or planned for the specific site. Interface with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity. Support Change Management activities Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Basic Qualifications: Doctorate Degree Or Master's Degree and 3 years of Regulatory CMC or related technical experience Or Bachelor's Degree and 5 years of Regulatory CMC or related technical experience Or Associates degree and 10 years of Regulatory CMC or related technical experience Preferred Qualifications: Regulatory CMC knowledge and experience Experience in manufacture, testing (QC/QA, distribution, or clinical), process development or other related Pharmaceutical/Biotech industry 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. 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. 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.