• Develop and apply deep and extended technical expertise of current regulatory, industry and emerging trends in compliance. • Develop, implement, and maintain a robust compliance framework that aligns with all applicable laws and regulations in Singapore. • Ensure timely and accurate submission of all regulatory reports to the relevant authorities (MAS, ACRA, IRAS). • Work closely with Legal, Finance, and People (HR) teams to ensure that all relevant regulations are identified and addressed.

Role Description This role is an exciting opportunity to join our dynamic and ambitious Regulatory Affairs team. The role is part-time and involves performing as Local Regulatory Affairs Expert providing consultancy services related to marketing authorizations and supporting regulatory activities for pharmaceutical products in Malta. Furthermore, candidates must be able and willing to legally work as a Freelancer and be based and have experience working in Malta. - Provides local regulatory consultancy and expert advice related to Marketing Authorization (MA) applications and amendments - Supports preparation, submission, and follow-up of MA applications and variations with local Health Authorities - Manages ongoing regulatory activities for authorized products to ensure continuous compliance with national requirements - Provides support for Decentralized Procedure (DCP) lifecycle management and national phase activities - Reviews and ensures alignment of product information, labelling, and packaging with local regulatory standards - Monitors national regulatory changes and communicates relevant updates to stakeholders - Provides ad-hoc regulatory support and guidance as needed - Collaborates closely with global and regional Regulatory Affairs teams to ensure consistency and compliance Qualifications - University Degree in Life Sciences, Pharmacy, or a related field - Minimum of 2 years of relevant experience in Regulatory Affairs, preferably within a global or regional pharmaceutical environment - Previous experience in marketing authorization applications, variations, and lifecycle management in Malta is highly valued Requirements - Strong organizational and analytical skills with a high level of attention to detail - Proven ability to work both independently and collaboratively in a dynamic, multinational context - A proactive, client-oriented mindset and the ability to manage multiple priorities efficiently - Proficiency in MS Windows and MS Office applications - Familiarity with national and EU regulatory systems (e.g., CESP, eCTD, DCP) is considered an asset - Excellent command of English (written and spoken) and local language - Knowledge of additional European languages is considered an advantage - Self-motivated, adaptable, and an effective communicator - A strong team player with a genuine interest in contributing to Excelya’s mission and supporting high-quality regulatory outcomes Benefits At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values of Audacity, Care, and Energy. - We combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare - We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience - Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects - Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey - Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential

• Own our security and compliance documentation accurate and up to date, such as policies, procedures, and support documentation across our information security and compliance programs. • Support our commercial teams in complex information security and compliance negotiations, while making sure we respond accurately and within given timescales. • Take ownership of maintaining our current ISO 27001 compliance and certification through continuous improvement activities, as well as supporting preparation for internal and external audits. • Own our internal Data Protection compliance program and make sure we comply with various regulations globally including UK GDPR, EU GDPR, and CCPA. • Gain experience in the implementation and ownership of additional compliance based projects as we increase the international regulation and standards we comply with. • Help us work efficiently by identifying common deal blockers and standardising documentation and processes.

Role Description RegASK is seeking a Regulatory Intelligence Specialist who is meticulous, organized, and confident in managing regulatory information workflows across global markets. You will coordinate closely with a network of subject matter experts, oversee the quality and relevance of regulatory content, and ensure that client requirements are accurately reflected throughout the monitoring process. This position is ideal for someone who enjoys working with diverse stakeholders, ensuring clarity and consistency in content delivery, and supporting the broader regulatory intelligence function in a fast moving environment. Key Responsibilities - Scope & Expert Management: - Manage the assignment of regulatory monitoring scopes across a global network of subject matter experts. - Provide onboarding and continuous training to experts to ensure understanding of client requirements and content standards. - Monitor expert performance, provide feedback, and maintain regular engagement to ensure alignment and accountability. - Content Oversight & Quality Assurance: - Oversee the collection, review, and validation of regulatory alerts and sources, ensuring accuracy, consistency, and relevance to client scopes. - Maintain high content quality and adherence to internal guidelines and delivery timelines. - Platform and Workflow Operations: - Support the operational execution & Client’s content set-up, ensuring smooth delivery through the platform. - Collaborate with the tech team to improve content integration, tagging, and automation workflows. - Contribute to the development and enhancement of the regulatory content database, including publishers and keyword tags. - Client and Internal Collaboration: - Ensure client scopes are accurately reflected in the monitoring workflow. - Support ad hoc projects such as horizontal scanning, content analytics, special client requests, and regulatory affairs projects (e.g., compliance reviews, regulatory overviews), acting as a subject matter expert or project lead when required. - Process Improvement: - Analyze existing workflows to identify gaps and inefficiencies and propose actionable solutions to improve operational efficiency. - Support the development and refinement of training materials, standard operating procedures (SOPs), and quality control checklists. - Drive ongoing process optimization initiatives to enhance team performance and content delivery. Qualifications - Background in Regulatory Affairs, Quality, Life Sciences, Public Health or a related discipline. - Education and or experience in Regulatory or Quality within the pharmaceutical and or medical device industries. - Fluent in English, with strong written and verbal communication skills. - Experience working with regulatory information or compliance centered workflows is an advantage. - Strong attention to detail with the ability to review, organize, and manage high volumes of information. - Comfortable collaborating with external experts and internal stakeholders, providing guidance and support where needed. - Analytical thinker able to identify gaps, suggest improvements, and support process enhancements. - Organized, proactive, and adaptable, with the ability to manage multiple priorities in a dynamic environment. Benefits - Flexible working arrangements (remote). - An opportunity to drive impact at the intersection of AI, SaaS, and regulatory intelligence. - Continuous learning and professional development. How to Apply If you are excited about this opportunity and believe you have the skills and qualifications to excel as our Regulatory Intelligence Specialist, please submit your resume for our consideration. We appreciate all applications, but only selected candidates will be contacted for an interview. Thank you for considering joining the RegASK team. We look forward to reviewing your application!