Senior Associate - Regulatory Affairs job at Amgen in US National

Senior Associate - Regulatory Affairs remote type Remote locations United States - Remote time type Full time job requisition id R-246261 Career Category Regulatory

Job Description

R-246261 Senior Associate - Regulatory Affairs What you will do Let’s do this. Let’s change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization. To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements. To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions To assist the Global Regulatory Lead to manage GRT interactions Key responsibilities include: Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings) Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead Create and maintain product regulatory information and history documents through Amgen systems Appropriately archive regulatory documents and agency communications Collaborate with CRO’s / partners to support site initiation Complete regulatory forms to support agency communications Participate in GRT to support execution of regulatory strategy Coordinate QC of regulatory documentation (e.g. briefing materials) Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) Assist in template development and maintenance Respond to specific requests from and communicate relevant issues to GRT Actively support regulatory compliance What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. Basic Qualifications: Master’s degree Or Bachelor’s degree and 2 years of Regulatory Affairs experience Or Associate’s degree and 6 years of Regulatory Affairs experience Or High school diploma / GED and 8 years of Regulatory Affairs experience Preferred Qualifications: Strong communication skills - both oral and written Ability to understand and communicate scientific/clinical information Ability to collaborate with team members to tackle problems and develop a course of action Cultural awareness and sensitivity to achieve global results Planning and organizing abilities Able to prioritize and balance multiple activities Ability to deal with ambiguity Ability to influence others What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: A 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 Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Salary Range 83,974.90USD -113,613.10 USD