Job Title:
Regulatory Data and Systems Senior Associate
Job Summary
Amgen is seeking a Regulatory Data and Systems Senior Associate for its Hyderabad location. This pivotal role focuses on managing and optimizing complex regulatory data systems that support global health authority submissions. The position demands a blend of technical expertise, data analysis, system optimization, and adherence to stringent regulatory guidelines, ensuring compliance and operational excellence in Amgen’s regulatory processes.
Key Responsibilities
Manage and optimize integrated data models ensuring regulatory compliance and system efficiency.
Interpret and implement business requirements aligned with Amgen's regulatory processes.
Analyze regulatory data to ensure adherence to global standards and health authority submission requirements.
Coordinate project planning, tracking, and execution for regulatory data initiatives.
Communicate regulatory updates and system improvements with stakeholders across departments.
Support system validation activities in accordance with GxP guidelines.
Required Skills & Qualifications
Bachelor’s degree with 2+ years OR Associate’s degree with 6+ years OR High school diploma with 8+ years in relevant roles.
5+ years of experience as a Business Analyst in the pharma/biotech industry.
Expertise in business analysis tools, SDLC, and agile development methodologies.
Knowledge of GxP requirements and regulatory systems validation processes.
Excellent communication and stakeholder management skills.
Ability to work effectively in a matrix environment, both independently and within teams.
Preferred Skills
Proficiency in Veeva Vault and global regulatory systems.
Familiarity with IDMP regulatory data standards.
5+ years of experience in data management, machine learning, or AI-related fields.
Knowledge of Agile methodologies (Scrum, Kanban) for efficient project delivery.
Perks & Benefits
Competitive salary and comprehensive Total Rewards Plan.
Opportunity to work with a global biotech leader.
Collaborative and inclusive work environment.
Continuous learning and professional development opportunities.
Company Description
Amgen is a globally renowned biotechnology company committed to discovering and delivering innovative medicines for serious illnesses. With a focus on therapeutic areas such as oncology, inflammation, and rare diseases, Amgen leverages cutting-edge technology to improve patient lives worldwide.
Work Mode
On-site (Hyderabad, India)
Salary/Compensation
Not disclosed in the job description.
Call to Action
If you are passionate about regulatory data management and compliance in the pharmaceutical industry, apply now to join Amgen’s mission to improve global health outcomes.
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