Regulatory Intelligence Manager
Role Objectives
TheRegulatory Intelligence Manageris responsible for proactively gathering, maintaining, and assessing critical regulatory intelligence relevant to unlicensed (EAP, PTA, PA-NPP), clinical trial, and commercial regulatory pathways. This role ensures the organization remains informed on evolving regulatory landscapes, emerging trends, and potential impacts on internal programs and client operations, while supporting compliance across managed access initiatives.
The Ideal Candidate
- Innovative
- Strategic
- Data-driven
- Analytical
- Detail-oriented
- Strong problem solver
Principal Duties and Responsibilities
Regulatory Monitoring and Research
- Maintain internal regulatory databases, ensuring all country summaries are kept current and reviewed periodically.
- Conduct in-depth, topic-specific regulatory research to support project-related strategies.
- Monitor regulatory databases, agency websites, industry publications, and expert networks to stay informed.
- Manage relationships with vendors or outsourced partners performing regulatory intelligence work, ensuring appropriate project cost allocation.
Regulatory Analysis and Interpretation
- Interpret regulatory information and summarize key requirements, translating insights into accessible documentation for internal use.
- Evaluate regulatory changes and partner across functions to identify opportunities or risks, ensuring effective communication to project teams.
Communication & Stakeholder Collaboration
- Liaise with regulatory agencies to support the development of the company’s regulatory intelligence resources.
- Present updates on evolving regulations to relevant internal stakeholders.
- Build and maintain relationships with key regulatory contacts, including agencies and vendors.
Process Development and Optimisation
- Enhance end-to-end regulatory intelligence processes to ensure reliable, accurate information flow.
- Collaborate with stakeholders to implement improvements that strengthen compliance and operational efficiency.
Qualifications
- Bachelor’s degree (health or science discipline preferred)
- Minimum 4 years' experience in Regulatory Affairs or related fields involving clinical trials or unlicensed medicines
- Strong ability to interpret legislation and translate regulatory requirements
- Skilled in regulatory research and summary reporting
- Proven ability to manage multiple priorities in a fast-paced environment
- Excellent written and verbal communication
- Comfortable with ambiguity and capable of providing structure and clarity
- Strong organizational skills and attention to detail
- Enthusiasm for process improvement and continuous development
- Proficient in Microsoft Office and general IT literacy
- Self-motivated and collaborative
- Able to handle confidential information with discretion
What’s Offered
- Private healthcare insurance
- Long-term illness cover
- Death-in-service benefits
- Salary sacrifice pension scheme
- Generous annual leave
- Paid maternity & paternity leave
- One paid volunteer day annually
About the Organization
This organization partners with pharmaceutical sponsors to enable patients and physicians to access medicines outside of standard commercial channels when no other treatments are available. With more than 15 years of experience, the company has delivered medicines to over 120 countries to support unmet medical needs.
Services include:
- Access Programs
- Clinical Trial Services
- Patient Site Solutions
- Clinical Trial Supply
- Market Access & Commercialization
