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Regulatory Affairs Associate
ParexelClinical Trial Submission Lead managing regulatory applications and project coordination for global clinical trials. Collaborating with cross-functional teams to ensure timely and compliant submissions.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Application submissions, project management, and regulatory compliance within global environments. Proven ability to manage risks, build stakeholder relationships, and monitor key performance indicators to ensure timely and quality deliverables.
Highest-signal resume keywords
Clinical Trial Application SubmissionsProject ManagementRegulatory ComplianceStakeholder Relationship ManagementRisk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ApplicationRegulatory RequirementsProject ManagementKPI MonitoringQuality Investigations
Soft Skills
Conflict ResolutionCollaboration
Industry Keywords
Life SciencesPharmacyPharmaceuticalCROEU CTRROW CTAClinical TrialsGlobal Regulatory Environments
About the role
Key responsibilities & impact- Lead end-to-end CTA project management across multiple studies and countries
- Plan, track, and deliver submissions aligned with timelines and regulatory requirements
- Manage risks, dependencies, and complexities in global regulatory environments
- Apply knowledge of EU CTR and ROW CTA requirements
- Manage core clinical and regulatory documentation
- Collaborate with cross-functional global teams
- Build and maintain stakeholder relationships and resolve conflicts
- Monitor KPIs related to timelines and deliverable quality
- Identify risks and lead quality investigations as needed
Requirements
What you’ll need- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- Minimum 3+ years of industry experience in pharmaceutical, CRO, or similar
- Experience in Clinical Trial Application submissions (EU CTR & ROW)
- Strong project management experience in a global/matrix environment
- Familiarity with clinical trials and regulatory processes
Benefits
Comp & perks- Health insurance
- Professional development opportunities