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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 submission processes, and compliance. Proven ability to manage cross-functional teams and enhance regulatory submission management through effective communication and leadership.
Highest-signal resume keywords
Regulatory Affairs ExperienceEU Drug Development KnowledgeCTA Submission ProcessesProject Management SkillsCross-Functional Team Coordination
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 Documentation ManagementDossier DevelopmentSubmission ManagementRegulatory InteractionProcess ImprovementQuality AssuranceRegulatory Frameworks KnowledgeClinical Research ExperienceVendor Relationship Management
Soft Skills
Strong CommunicationOrganizational SkillsProblem-Solving SkillsLeadership Skills
Tools & Technologies
Regulatory Submission Tracking SystemsElectronic Document Management Tools
Certifications & Qualifications
Bachelor's Degree in Life ScienceAdvanced Degree in Life Science or Regulatory Affairs Preferred
Industry Keywords
Pharmaceutical IndustryHealthcareRegulated EnvironmentEU Regulatory RequirementsCTRCTISGlobal CTA Strategy
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
- Implement global CTA strategy
- Ensure quality and compliance with country-specific requirements across regulatory submissions
- 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
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
- Experience coordinating cross-functional teams and managing vendor relationships
- Experience in clinical research, healthcare, or a regulated environment
- Strong communication, organization, and problem-solving skills
- Advanced degree in Life Science, Regulatory Affairs, or related field preferred
- Familiarity with regulatory submission tracking systems and electronic document management tools preferred
- Knowledge of additional regulatory pathways beyond EU requirements preferred
Benefits
Comp & perks- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
- Paid time off
- Life insurance
- Additional benefit offerings in accordance with applicable plans
- Potential eligibility for additional incentives, bonuses, or other compensation programs