Regulatory Affairs Liaison

MSD

Regulatory Affairs Liaison coordinating regulatory activities for pharmaceuticals in EU, UK, and Switzerland. Managing submissions and communications with regulatory agencies to ensure compliance and strategy execution.

Posted 5/15/2026full-timeBrussels • 🇧🇪 BelgiumJuniorMid-LevelWebsite

About the role

Key responsibilities & impact

Coordinate the preparation, review, and submission of regulatory dossiers for new product registrations and post-approval submissions in the EU, UK, Switzerland, and non-EU SEE countries.
Work with cross-functional project teams to develop and implement regulatory strategies, including scientific advice, pediatric investigational plans, and orphan designation.
Identify regulatory risks and ensure alignment of regulatory strategies with project teams and business objectives.
Accountable for interacting with regulatory agencies and Country RA teams to facilitate smooth submission, assessment, and quick approval of CTAs under the EU Clinical Trial Regulation.
Serve as the primary regulatory representative to regulatory agencies and Country RA teams.
Act as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
Develop and implement effective processes to meet business objectives and ensure compliance with regulatory requirements.
Continuously build and maintain a sound scientific knowledge and expertise in assigned product areas and regulations.

Requirements

What you’ll need

Master's degree in pharmacy, chemistry, or equivalent, preferably in a science-related field.
Minimum of 2 years of experience in the pharmaceutical industry is preferred.
Strong organizational and planning skills, with the ability to manage multiple projects and adapt to changing priorities.
Knowledge of EU regulations, guidelines, and regulatory processes for product life cycle maintenance.
Ability to work in a cross-functional and international environment.
Fluent written and spoken English is required, along with strong interpersonal, oral, and written communication skills.
Digital & AI literacy (use of AI-enabled tools to support regulatory, administrative, and process-improvement activities).
Willingness to travel up to 5% for job-related activities.

Benefits

Comp & perks

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Hard Skills & Tools

regulatory dossier preparationregulatory strategies developmentscientific advicepediatric investigational plansorphan designationregulatory risk identificationEU Clinical Trial Regulationproduct life cycle maintenanceregulatory compliancescientific knowledge

Soft Skills

organizational skillsplanning skillsproject managementadaptabilityinterpersonal skillsoral communicationwritten communicationcross-functional collaborationinternational teamworkproblem-solving

Certifications

Master's degree in pharmacyMaster's degree in chemistryequivalent science-related degree