Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance

Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance In this vital role you will provide strategic direction for product and disease communications and activities by interpreting the current FDA regulatory environment to ensure truthful and non‑misleading communication to the health care community, patients, and the public. This position is primarily responsible for formulating and communicating the regulatory promotional position for approved and/or pipeline products. Key Responsibilities Promotional review committee experience in evaluating proposed pieces and supporting evidence Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen Update the Promotions group on new learnings and key takeaways from courses, congresses, and tradeshows Mentor Senior Associate and Manager level reviewers Assess promotional programs against regulatory requirements Identify changes required to meet promotional regulations Basic Qualifications Doctorate degree and 2 years of related experience Masters degree and 4 years of related experience Bachelors degree and 6 years of related experience Associates degree and 10 years of related experience High school diploma / GED and 12 years of related experience Preferred Qualifications Serves as an advertising and promotions technical authority within the organization Experience in reading, understanding, and applying promotional regulations to a constantly changing environment Experience in an environment requiring extensive daily negotiation, persuasion, collaboration, and analytical judgment Experience understanding and interpreting data and its practical application Leadership, strategic focus, collaboration, independence, clinical knowledge, analytical judgment, negotiation/persuasion skills, coaching and mentoring skills, project management skills, problem solving skills, time management skills, organization Benefits 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 comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward 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 Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. 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. #J-18808-Ljbffr BioSpace