Job Title: Regulatory Affairs Intelligence Manager
Location: Hyderabad, India
Job ID: R-218764
Category: Regulatory
About Amgen
At Amgen, our mission is to serve patients suffering from serious illnesses by pioneering innovative biotech solutions. Since 1980, we have been at the forefront of biotechnology, focusing on Oncology, Inflammation, General Medicine, and Rare Diseases. Our award-winning culture fosters collaboration, innovation, and scientific excellence, making Amgen a great place to grow your career while making a meaningful impact on global healthcare.
Job Description: Manager, Global Regulatory Intelligence
Key Responsibilities
1. Intelligence Gathering & Analysis
- Monitor and analyze the global regulatory landscape to identify changes impacting drug development and approvals.
- Collect and synthesize local regulatory requirements from Amgen’s regional teams.
- Prepare regulatory intelligence reports, bulletins, and summaries to support upcoming filings.
- Ensure deliverables are actionable, clear, and aligned with business needs.
2. Tools & Data Management
- Maintain and optimize regulatory intelligence databases, dashboards, and tracking tools.
- Develop new tracking systems or dashboards to enhance regulatory monitoring efficiency.
- Ensure all regulatory intelligence repositories are updated and accessible to stakeholders.
3. Cross-Functional Support
- Collaborate with Regulatory Policy, Product Teams, and Compliance to integrate intelligence into decision-making.
- Provide data-driven insights to support global regulatory strategies.
- Address internal stakeholder requests efficiently and accurately.
4. Progress Tracking & Improvement
- Monitor intelligence activities against timelines and objectives.
- Identify process inefficiencies and suggest improvements.
- Contribute to continuous improvement of regulatory intelligence workflows.
Required Skills & Qualifications
Education & Experience
- Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field (Master’s preferred).
- 3-5 years of experience in Regulatory Affairs, Compliance, or Drug Development.
- Prior experience in Regulatory Intelligence or Policy Tracking is a plus.
Technical & Analytical Skills
- Strong data analysis and interpretation skills.
- Proficiency in regulatory intelligence tools (e.g., Tarius, Cortellis, FDA/EMA databases).
- Experience with database management, SharePoint, or dashboard tools.
- Excellent written and verbal communication skills.
Soft Skills
- High attention to detail and ability to distill complex regulations into clear insights.
- Strong project management and multitasking abilities.
- Proactive mindset with a problem-solving approach.
Why Join Amgen?
- Competitive salary & benefits aligned with industry standards.
- Inclusive & collaborative work culture.
- Opportunities for professional growth in a global biotech leader.
- Impactful work that transforms patient lives worldwide.
How to Apply
Ready to advance your career in Regulatory Intelligence? Apply now for the Regulatory Affairs Intelligence Manager role at Amgen Hyderabad!
