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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in regulatory affairs, particularly in EU Clinical Trial Applications (CTAs) and CTIS lifecycle management, while providing strategic regulatory advice and maintaining strong client relationships. Proficient in project management, regulatory documentation, and compliance with evolving regulations.
Highest-signal resume keywords
Regulatory Affairs ExperienceEU Clinical Trial Applications (CTAs)CTIS Lifecycle ManagementRegulatory Strategy DevelopmentProject Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory Documentation PreparationEU Regulatory StrategyClinical Trial RegulationsBudget ManagementDocumentation Gap AssessmentsCombination Product TrialsStakeholder ManagementProject Timeline PlanningScientific Advice StrategyRegulatory Intelligence
Soft Skills
Client Relationship ManagementMentoring and GuidanceExcellent Communication SkillsProblem-SolvingTeam Collaboration
Tools & Technologies
Microsoft OfficeRegulatory SystemsPublishing Tools
Certifications & Qualifications
Applicable Regulatory Certifications
Industry Keywords
PharmaceuticalBiotechnologyCRORegulatory ComplianceStandard Operating Procedures (SOPs)Reporting Member States (RMS)Clinical TrialsLifecycle ManagementBid Defense MeetingsCross-Functional Initiatives
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- Bachelor's Degree in Life Sciences or a related discipline required
- Master's Degree in Life Sciences or a related discipline preferred
- 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
Benefits
Comp & perks- Full-time employment
- Diversity, inclusion, and belonging culture
- Opportunity to work on global, regional, and cross-functional initiatives
- Training and professional development support
- Opportunity to participate in global initiatives and process improvement activities