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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory affairs with a strong focus on EU drug development, CTA submissions, and compliance. Proven ability to manage cross-functional teams and vendor relationships while ensuring quality and timely regulatory interactions.
Highest-signal resume keywords
Regulatory Affairs ExperienceEU Drug Development KnowledgeCTA Submission ProcessesProject Management SkillsLeadership in Regulatory Documentation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory ComplianceCTA DocumentationDossier DevelopmentRegulatory Submission ManagementQuality AssuranceProcess ImprovementAttention to DetailClinical Research ExperienceKnowledge of Regulatory PathwaysFamiliarity with Regulatory Tracking Systems
Soft Skills
Excellent CommunicationOrganizational SkillsCollaborationProblem-Solving Skills
Tools & Technologies
Electronic Document Management ToolsRegulatory Submission Tracking Systems
Industry Keywords
Pharmaceutical IndustryHealth AuthoritiesCRO ManagementEU Regulatory RequirementsCTRCTISRegulated Environment
About the role
Key responsibilities & impact- Provide operational and regulatory support for CTA submissions and maintenance activities
- Prepare and coordinate global CTA and amendment documentation
- Manage dossier development and ensure quality and completeness
- Manage or facilitate submissions to health authorities or via local personnel
- Serve as the primary point of contact for regulatory interactions
- Liaise with and oversee CROs for submissions and query management
- Ensure timely and accurate responses to regulatory inquiries
- Implement global CTA strategy
- Ensure quality and compliance with country-specific requirements
- Maintain tracking and archiving of regulatory submissions
- Communicate EU regulatory requirements and updates to cross-functional teams
- Contribute to process improvements in regulatory submission management
- Collaborate with cross-functional teams and follow industry-standard processes from planning through closeout
Requirements
What you’ll need- Bachelor's degree in Life Science or equivalent experience
- 6+ years in pharmaceutical industry with 5+ years in Regulatory Affairs
- Strong knowledge of EU drug development, CTR, and CTIS regulatory frameworks
- Demonstrated experience with CTA submission processes and regulatory compliance
- Proven leadership in EU CTA documentation and submissions
- Strong knowledge of EU drug development, CTR, and CTIS workflows across multiple jurisdictions
- Project management and leadership skills
- Ability to coordinate cross-functional teams and manage vendor relationships
- Excellent communication, organization, collaboration, and problem-solving skills
- Experience in clinical research, healthcare, or a regulated environment
- Strong attention to detail and quality mindset
- Familiarity with regulatory submission tracking systems and electronic document management tools
- Knowledge of additional regulatory pathways beyond EU requirements is preferred
- Ability to work ET hours; eastern or central time zone of Canada highly preferred
Benefits
Comp & perks- Competitive salaries based on position, level, skills, education, training, experience, professional achievements, and location
- Some roles may be eligible for additional incentives, bonuses, or other compensation programs
- Flexibility
- Growth opportunities
- Space to do your best work
- Continuous learning opportunities