Regulatory Compliance Change Assessor - Manager

<h2><b>Career Category</b></h2>Regulatory<h2></h2><h2><b>Job Description</b></h2><div><div><p>Let’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead.</p><p>The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level.</p><h2></h2><h2>Roles &amp; Responsibilities:</h2><p>Key responsibilities of the Regulatory Manager include:</p><ul><li><p>Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope.</p></li><li><p>Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system.</p></li><li><p>Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies</p></li><li><p>Provides expertise and guidance to interdepartmental and cross-functional teams</p></li><li><p>Coaches and support junior regulatory staff’s career development</p></li><li><p>Identifies and implements process improvements for the change management process</p></li></ul><h2></h2><h2><b>What we expect of you</b></h2><p>We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.</p><p></p><p><b>Basic Qualifications:</b></p><ul><li><p>Doctorate degree OR</p></li><li><p>Master’s degree and 4 to 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR</p></li><li><p>Bachelor’s degree and 6 to 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR</p></li><li><p>Diploma and 10 to 12 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry</p></li></ul><p></p><p><b>Preferred Qualifications:</b></p><ul><li><p>Degree in Life Science discipline</p></li><li><p>Regulatory CMC specific knowledge &amp; experience</p></li><li><p>Understanding and application of principles, concepts, theories and standards of scientific/technical field</p></li><li><p>Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry</p></li></ul><h2></h2><h2><b>What you can expect of us</b></h2><p>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.</p><p>In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p><h2><b>Apply now</b></h2><p><b>for a career that defies imagination</b></p><p>Objects in your future are closer than they appear. Join us.</p><h2><b>careers.amgen.com</b></h2><p></p></div></div><div><div><p><span> </span></p></div></div><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.