Regulatory Manager, Intelligence Services

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🕒 March 24

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Bionical Emas

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1998

💊 Pharmaceuticals

🤝 B2B

Pharmaceuticals • B2B

Bionical Emas is a B2B life sciences services company that provides clinical development and pharmaceutical support, including clinical trial supply, regulatory affairs, pharmacovigilance, medical affairs, quality assurance, and distribution/logistics. The company appears to support pharmaceutical and biotech organizations with trial management, patient access, and related operational services, and recruits professionals across these functions.

📋 Description

• 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