Regulatory Affairs Manager

This is a fully remote position, open to applicants in Belgium, +4 more countries.

📋 Description

• Provide expertise in regulatory affairs, client engagement, strategic regulatory intelligence, and guidance supporting product development from preclinical stages through to registration and product optimization.

• Take ownership of regulatory decision-making for assigned clinical programs.

• Propel cross-functional clinical trial teams towards the execution of regulatory strategies and the attainment of program objectives.

• Convert indication-level regulatory strategies into practical trial-level strategies and execution plans.

• Define regulatory pathways, set priorities, deliverables, dependencies, risks, and timelines.

• Stay updated on legislation, regulatory requirements, guidelines, and emerging regulatory developments.

• Act as the regulatory subject-matter expert across global, regional, and country-specific requirements.

• Integrate regulatory requirements, dependencies, risks, and timelines into operational plans in collaboration with Clinical Operations and other functions.

• Establish regulatory priorities and accountabilities while identifying issues that may impact deliverables or milestones.

• Facilitate cross-functional discussions to navigate regulatory challenges, ensuring decisions are documented, communicated, and acted upon.

• Escalate significant regulatory risks and strategic issues while maintaining accountability for follow-through and resolution.

• Participate in launch meetings, project reviews, governance discussions, and project team meetings.

• Lead the development of global regulatory strategies and the preparation of submissions to Regulatory Authorities and Ethics Committees.

• Provide senior review and strategic counsel for regional regulatory submissions.

• Ensure that regulatory deliverables are accurate, consistent, compliant, and delivered punctually.

• Maintain compliance with organizational and regulatory SOPs, WPDs, policies, and procedures.

• Uphold quality performance across assigned and managed projects.

• Oversee project budgets and forecasting activities.

• Identify out-of-scope activities and assist with contract modifications.

• Maintain effective client interactions and communicate recommendations, risks, and options.

• Collaborate with Business Development on pricing and new business opportunities, client presentations, proposals, scopes, and budgets.

• Provide matrix/project leadership, coaching, training, and guidance to junior team members.

⛳️ Requirements

• Bachelor’s degree or an equivalent relevant formal academic/vocational qualification.

• Typically, 9+ years of relevant experience.

• A combination of appropriate education, training, and directly related experience may also be considered.

• Outstanding written and verbal communication skills in English, as well as local language proficiency where applicable.

• Ability to make and own regulatory decisions while balancing regulatory needs, strategic objectives, operational feasibility, risks, and timelines.

• Strong leadership and influencing skills in a matrix environment.

• A solid operational mindset with the capability to translate regulatory strategies into executable plans, milestones, dependencies, and actions.

• Ability to identify regulatory and operational risks, assess options, recommend actions, and drive resolutions.

• Experience with Platform Protocols and Integrated Protocol Designs is highly desirable.

• Exceptional interpersonal and stakeholder-management abilities.

• Excellent negotiation and conflict-resolution skills.

• Capacity to work independently and exercise sound judgment.

• Comprehensive understanding of global, regional, and national regulatory requirements and procedures for clinical trial authorization, licensing, registration, and lifecycle management.

• Expert knowledge of ICH guidelines and other relevant global regulatory standards.

• Advanced expertise in one or more regulatory specialty areas, such as clinical, preclinical, CMC, publishing, or related fields.

• Strong understanding of medical terminology, statistical concepts, and pertinent scientific and regulatory guidelines.

• Excellent analytical, investigative, decision-making, and problem-solving skills.

• Strong organizational, planning, and time-management abilities.

• Excellent attention to detail, quality assurance, editorial review, and proofreading skills.

• Advanced understanding of project budgeting and forecasting.

• High proficiency with Microsoft Word, Excel, and PowerPoint.

• Willingness to learn and adopt new technologies.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Occasional domestic and international travel.

• Preferential treatment for severely disabled applicants with equivalent aptitude.