Regulatory Intelligence Professional
2 days ago
Regulatory Affairs Intelligence Managers are responsible for monitoring and analyzing the global regulatory landscape, gathering intelligence, and providing strategic recommendations to support business decisions.
Key Responsibilities:- Monitor regulatory requirements and changes in assigned therapeutic or regional areas.
- Compile and synthesize new or updated regulatory information from local affiliates.
- Develop deliverables such as monitoring reports, bulletins, and landscape summaries.
- Evaluate the impact of regulatory changes on product lifecycle and submissions.
Tools & Data Management:
- Manage and maintain regulatory intelligence tools, databases, and repositories.
- Ensure systems are up-to-date and accessible by stakeholders.
- Build or configure dashboards, tracking tools, or databases as needed.
Cross-Functional Support:
- Collaborate with Regulatory Policy, Product Regulatory Leads, and other stakeholders.
- Provide timely data or regulatory insights for product strategy discussions.
- Support cross-functional initiatives by offering relevant regulatory intelligence.
Progress Tracking & Process Improvement:
- Track progress against intelligence gathering plans and timelines.
- Report regularly on task status and potential bottlenecks.
- Identify and propose process enhancements to increase efficiency or accuracy.
Required Skills & Qualifications:
- Bachelor's degree in life sciences, regulatory affairs, or a related field (Master's preferred).
- 3–5 years of experience in regulatory affairs, regulatory operations, or related drug development roles.
Preferred Background:
- Experience in regulatory intelligence or regulatory policy tracking.
- Familiarity with tools like Tarius or other regulatory subscription databases.
- Previous work in pharmaceutical or biotech industry with a global regulatory focus.
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