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Regulatory Manager, Intelligence Services

ComplianceComplianceFull TimeRemoteSeniorTeam 51-200Since 1998H1B No SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

87 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Regulatory Manager, Intelligence Services

Bionical Emas

• 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

Job 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

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