FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs and Clinical Trial submissions, with a strong focus on EU CTR and CTIS processes. Capable of managing timelines, coordinating responses, and ensuring compliance with regulatory requirements while mentoring junior team members.
Highest-signal resume keywords
Regulatory Affairs ExperienceEU CTR Submission ExpertiseCTIS Application ManagementRegulatory Submission Strategy DevelopmentStrong Organizational Skills
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 SubmissionsClinical Trial Start-UpCTIS WorkflowsSubmission Strategy DevelopmentQuality CheckingRisk IdentificationSOP DevelopmentTimeline ManagementAuthority Query ResponseProcess Improvement
Soft Skills
Confident CommunicationCross-Functional CollaborationMentoring
Tools & Technologies
CTIS
Industry Keywords
Life SciencesPharmaBiotechCRORegulatory AuthorityIRBEthics CommitteeThird BodyGlobal Regulatory RequirementsClinical Trials
About the role
Key responsibilities & impact- Own and manage Regulatory Authority (RA), IRB/EC, and Third Body submissions for assigned clinical trials
- Develop submission strategy, planning, and timeline management
- Track approvals against project milestones (GL, RTE)
- Coordinate responses to authority queries within defined timelines
- Lead or support EU CTR submissions via CTIS
- Prepare, submit, and maintain CTIS applications
- Manage CTIS user access and act as CTIS back-up when required
- Advise internal teams on CTR/CTIS processes and expectations
- Prepare, review, and quality-check core and country-specific regulatory submission packages
- Ensure deliverables comply with applicable regulations, guidance, SOPs, and client requirements
- Provide regulatory guidance by maintaining up-to-date knowledge of global and EU regulatory requirements
- Liaise with or support local teams in communications with Regulatory Authorities, Ethics Committees, and Third Bodies
- Identify and proactively escalate risks to timelines, quality, or approvals
- Support audits, inspections, and resolution of findings
- Contribute to process improvement initiatives, including SOP development and optimization
- Mentor junior team members and support team capability building
Requirements
What you’ll need- Bachelor’s degree in Life Sciences or a related field (or equivalent experience)
- Minimum 4 years of experience in Regulatory Affairs, Regulatory Submissions, or Clinical Trial Start‑Up within pharma, biotech, or CRO
- Hands-on experience with EU CTR and CTIS is required
- Experience preparing and submitting applications in CTIS
- Experience managing CTIS workflows, timelines, and user access
- Experience responding to CTIS-related authority questions
- Solid understanding of RA, IRB/EC, and Third Body submission processes
- Experience supporting global or regional clinical trials
- Strong organizational skills with the ability to manage multiple submissions and deadlines
- Confident communication and ability to work with cross-functional and client stakeholders