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Regulatory Manager, Intelligence Services at Bionical Emas | JobVerse
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Regulatory Manager, Intelligence Services
Bionical Emas
Remote
Website
LinkedIn
Regulatory Manager, Intelligence Services
United Kingdom
Full Time
9 hours ago
Apply Now
Key skills
AI
Version Control
Leadership
Communication
About this role
Role Overview
Act as a subject matter expert on global regulatory frameworks for expanded access, compassionate use, and pre-approval access pathways
Maintain and update the regulatory intelligence database ensuring accuracy, compliance, and relevance
Liaise with global health authorities to obtain regulatory clarification, drafting strategic inquiries for targeted responses
Lead structured regulatory surveillance to track global regulatory changes and share timely updates with internal teams
Translate complex regulatory updates into actionable insights to support decision-making across departments
Develop and present regulatory intelligence reports and dashboards tailored for senior leadership and cross-functional teams
Manage and maintain country-level regulatory data across internal systems, ensuring clarity, consistency, and version control
Collaborate with internal stakeholders to refine regulatory processes and integrate local insights into the intelligence database
Utilize AI and digital tools to enhance regulatory intelligence capabilities and system efficiency
Support regulatory-focused client projects by delivering high-quality intelligence summaries and liaising directly with clients
Requirements
Bachelor’s degree in life sciences, pharmacy, or related field; advanced regulatory qualification preferred
Previous experience in regulatory affairs or intelligence within biotech, pharma, CRO is essential
Hands-on experience with Early Access / Expanded Access / Compassionate Use / Named-Patient / Post-Trial Access programs
Strong regulatory intelligence skills, including monitoring, interpreting, and communicating global regulatory update
Confident client-facing communicator, able to explain complex regulatory concepts, manage stakeholders, and represent the business externally
Highly organised, detail-driven, and able to work independently as a proactive self-starter
Excellent written and verbal communication skills in English; additional languages are a plus
Experience with Market Access, clinical trial regulations, and digital / AI-enabled regulatory tools is desirable
Benefits
25 days of vacation
Vacation days purchasing scheme
1 extra vacation day per each 3 years of service
Discretionary Annual Bonus
Sabbatical of 3 to 6 months (after 2 years of service)
Free food and beverages at all offices
Life Insurance
Health Insurance and Employee Assistance Programme
Employee Support Networks – help us continue to build on our inclusive culture
Flexible and hybrid work
Apply Now
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