Job Description

Description Fully remote- PST working hours are preferable Global Regulatory Policy and Intelligence engages regulators industry and professional associations and patient advocates externally and subject matter experts across Amgen to advance important Regulatory policy issues aligned with Amgens goals and priorities. It also manages Regulatory Intelligence for the Global Regulatory Affairs organization enabling fast efficient global filings by effectively monitoring analyzing and communicating regulatory requirements to regulatory strategy leads and others involved in the delivery of regulatory submissions and approvals. The Sr. Associate Regulatory Intelligence role performs monitoring and analysis of the global regulatory landscape according to defined plans and priorities and delivers agreed regulatory intelligence outputs. - Uses internal and external contacts tools and systems to gather regulatory intelligence - Applies professional skills and experience with advanced tools to summarize and contextualize regulatory intelligence information and identify trends in agency feedback - Works with limited supervision according to predefined regulatory intelligence workplans - Applies tools and systems to deliver agreed intelligence objectives - Communicates progress and escalates issues impacting delivery of intelligence outputs Day to day responsibilities: 1. RI Gathering, Monitoring & Surveillance. Identify and document key regulatory requirements for global submissions. Track updates from global regulatory authorities (e.g., FDA, EMA, MHRA, PMDA, TGA) and internal contacts. Monitor industry newsletters, journals, press releases, and competitor activity. Set alerts in regulatory intelligence platforms (e.g., Cortellis, IQVIA) for new guidance's, legislation, or enforcement trends. 2. Database & Knowledge Management. Maintain a centralized regulatory intelligence repository (e.g., SharePoint, internal dashboards). Ensure historical tracking and tagging of relevant changes for future reference. 3. Communication & Reporting. Draft and distribute regulatory intelligence newsletters or briefs. Prepare summaries or presentations on key changes. Update internal stakeholders (Regulatory Affairs, Quality, Clinical, R&D, etc.) on high-impact developments. Skills regulatory, clinical research, regulatory affairs, regulatory documents, regulatory submission, regulatory compliance, fda, ich gcp, research and analysis, regulatory data, tga, sharepoint, quality assurance, compliance, clinical trial, r&d Top Skills Details regulatory,clinical research,regulatory affairs,regulatory documents,regulatory submission,regulatory compliance,fda,ich gcp,research and analysis,regulatory data,tga,sharepoint,quality assurance,compliance,clinical trial,r&d Additional Skills & Qualifications Master's degree OR Bachelor's degree and 2 years of experience OR Associate's degree and 4 years of experience OR High school diploma / GED and 6 years of experience Ideal candidate: Job seeker who has couple of years industry experience outside of college with life science bg 1. Regulatory Knowledge & Analytical Thinking. Strong understanding of global regulatory frameworks (FDA, EMA, ICH, etc.). Ability to interpret complex regulatory texts, guidance documents, and policy updates. 2. Research & Monitoring Proficiency. Experience in using regulatory intelligence tools and databases (e.g., Cortellis, Informa, IQVIA). Continuous scanning of health authority websites, publications, and competitor activity. Ability to synthesize large volumes of information into concise, actionable insights. 3. Communication & Strategic Influence. Strong written and verbal communication skills to translate regulatory developments into clear guidance. Ability to create reports, and alerts for cross-functional teams. Experience Level Entry Level Pay and Benefits The pay range for this position is $20.00 - $26.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision- Critical Illness, Accident, and Hospital- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available- Life Insurance (Voluntary Life & AD&D for the employee and dependents)- Short and long-term disability- Health Spending Account (HSA)- Transportation benefits- Employee Assistance Program- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on May 5, 2025. About Aston Carter: Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service. Diversity, Equity & Inclusion At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.

Job Tags

Temporary work, Remote work,

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