Regulatory Data & Systems Senior Associate

As a Regulatory Data & Systems Senior Associate at the company, your role will involve interpreting and implementing business requirements in alignment with industry best practices and Amgen regulatory processes. You will focus on optimizing complex data systems for health authority submissions and ensuring regulatory compliance. **Roles & Responsibilities:** - **Data Administration/AI:** Optimize and maintain the organization's complex data models to ensure integration, efficiency, and regulatory compliance. - **Regulatory Business Analysis:** Interpret and implement regulatory requirements to ensure systems and processes meet relevant standards. - **Project Coordination:** Assist in planning, tracking, and executing departmental projects and initiatives. - **Stakeholder Communication:** Liaise with internal and external stakeholders for timely and accurate communication on regulatory requirements and system updates. **Required Knowledge and Skills:** - Strong interpersonal and teamwork skills to collaborate with various stakeholders. - 5+ years" experience as a business analyst with a command of business analysis techniques, SDLC, and agile methodologies. - Excellent oral and written communication skills for presenting ideas convincingly. - Ability to work effectively in a matrix environment, balancing teamwork and independent work. - Familiarity with GxP requirements and systems validation. - Experience in the Life Sciences, Biotech, or pharmaceutical industry. **Preferred Knowledge and Skills:** - Advanced knowledge of Veeva Vault. - Familiarity with global regulatory processes and standards. - Proficiency in Agile methodologies like Scrum or Kanban for enhanced collaboration and efficiency. **Basic Education and Experience:** - Bachelors degree with 2 years of directly related experience. - Associates degree with 6 years of related experience. - High school diploma / GED with 8 years of related experience. **Preferred Education and Experience:** - Practical experience with regulatory data standards such as IDMP. - 5+ years of experience in data management, machine learning, or related fields.,