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Rho · 3 days ago
Senior Regulatory Intelligence Manager
United States
Full-time
Remote
Senior Level
7+ years exp
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Responsibilities
Monitor and analyze global regulatory developments, including new regulations, guidelines, and enforcement actions, in countries and regions of interest for Rho’s business.
Establish and maintain a comprehensive database of regulatory intelligence resources and ensure timely dissemination of relevant information to project leads and key stakeholders.
Establish and maintain country-level requirements for clinical trial applications and associated clinical trial reporting requirements including pharmacovigilance/safety reporting.
Provide regulatory intelligence in support of strategic and operational planning and execution activities for new clinical trial and regulatory project proposals and ongoing projects.
Assess the impact of regulatory changes on projects led by Rho’s Commercial and Federal Sectors, including regulatory strategy & submissions, biometrics, and clinical trial projects.
Prepare detailed reports and briefing documents for project teams and senior management upon request.
Provide regulatory intelligence input for regulatory risk assessments and strategies to mitigate potential regulatory risks for project teams and clients.
Collaborate with internal stakeholders to ensure alignment on compliance initiatives.
Advise clients and project teams on regulatory trends and their impact on project and product development strategy.
Conduct training sessions and workshops to educate teams on regulatory developments and implications for projects.
Qualification
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Required
University degree is required; advanced degree is preferred.
Minimum of 7 years of experience in regulatory affairs, with at least 3 years in a regulatory intelligence role.
Extensive experience in the pharmaceutical, biotechnology, or medical device industries.
Proven track record of successfully managing regulatory intelligence projects and influencing regulatory policy.
In-depth knowledge of global regulatory frameworks and guidelines (FDA, Health Canada, EMA, MHRA, PMDA, etc.).
Strong analytical and problem-solving skills, with the ability to interpret complex regulatory information and provide actionable insights.
Excellent written and verbal communication skills, with the ability to effectively present information to diverse audiences.
Strong project management skills and the ability to handle multiple priorities in a fast-paced environment.
Proficiency with regulatory intelligence databases and software tools.
Preferred
Advanced degree.
Benefits
Comprehensive benefits package
Generous paid time off
Holidays
Parental leave
Bereavement leave
Company
Rho
Rho is a pharmaceuticals company that offers clinical drug development services.
501-1,000 employees
Funding
Current Stage
Early StageTotal Funding
unknown1984-10-24Angel· Undisclosed
Leadership Team
Laura Helms Reece
Chief Executive Officer
Mark Ubert
Chief Financial Officer
Recent News
2024-05-29
2024-05-26
2023-11-19
Company data provided by crunchbase
