Job Description

Regulatory Affairs Manager

Budapest, Hungary | Home-based

Individual contributor with advanced knowledge acquired from at least 8 years of relevant industry experience. Working independently with limited supervision, the individual will provide strategic regulatory expertise and leadership for clinical trial applications and lifecycle management activities, with a strong focus on EU Clinical Trials Regulation (CTR) submissions and Clinical Trials Information System (CTIS) management.

Essential Functions

• Act as Regulatory Global Team Leader for regulatory projects and/or serve as Regulatory Project Manager for stand-alone projects
• Lead the preparation, review, and submission of regulatory documentation, ensuring high quality and compliance with applicable regulations and guidelines
• Provide strategic regulatory advice to clients, including EU submission strategy, Reporting Member State (RMS) selection, scientific advice planning, and lifecycle management activities
• Lead and support EU CTR submissions, including initial CTA submissions, substantial modifications, Requests for Information (RFIs), and CTIS lifecycle activities
• Manage communications and interactions with regulatory authorities, including support for and participation in agency meetings.
• Build and maintain strong client relationships, acting as a trusted advisor on regulatory matters and proactively resolving issues
• Manage project timelines, deliverables, budgets, and out-of-scope activities to ensure successful project execution and financial performance
• Mentor and provide guidance to junior colleagues, including review of regulatory documentation and support for training and professional development
• Support business development activities, including travelling to and participating in bid defense meetings and client presentations
• Contribute to the development, revision, and review of regulatory and cross-functional Standard Operating Procedures (SOPs)
• Support global, regional, and cross-functional regulatory initiatives and process improvement activities
• Remain current with regulatory intelligence, evolving regulations, and industry best practices
• Perform additional duties as assigned to support business and departmental objectives

Qualifications

• Bachelor's Degree in Life Sciences or a related discipline required
• Master's Degree in Life Sciences or a related discipline preferred

Experience

• Minimum of 8 years of regulatory affairs experience within the pharmaceutical, biotechnology, CRO, or related industry
• Minimum of 2 to 3 years of hands-on EU CTR and CTIS experience, including preparation, review, and submission of Part I initial Clinical Trial Applications (CTAs)
• Demonstrated experience managing CTIS lifecycle activities, including RFIs, substantial modifications, and ongoing trial maintenance
• Experience interacting with Reporting Member States (RMS) and other European regulatory authorities
• Proven experience advising clients on EU regulatory strategy, including RMS selection, submission planning, and scientific advice strategy
• Advanced understanding of EU clinical trial regulations, guidance documents, and CTIS requirements
• Strong understanding of regulatory documentation requirements across different therapeutic areas, development stages, and product modalities
• Experience with combination product trials is advantageous
• Experience in regulatory strategy development, timeline planning, budget management, and documentation gap assessments
• Ability to independently manage multiple projects and priorities while meeting challenging timelines

• Strong project leadership and stakeholder management skills
• Excellent written and verbal communication skills, including preparation of high-quality regulatory documents and client-facing presentations
• Ability to establish and maintain effective relationships with clients, colleagues, and regulatory authorities
• Proficiency in Microsoft Office and relevant regulatory systems and publishing tools
• Applicable certifications and licenses as required by local regulations and business needs
• Willingness to support cross-functional and global initiatives as required

Where you'll work

Home-based

You'll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you'll stay connected while enjoying the autonomy and balance that comes with a fully remote role.

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