CTIS Submission Manager
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Poland
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About the role
- Leading the preparation, submission, and maintenance of regulatory documents for EU CTIS submissions.
- Providing expertise and guidance on regulatory requirements and standards to internal teams.
- Interfacing with regulatory agencies to address inquiries, submissions, and approvals.
- Monitoring changes in regulations and guidelines to ensure compliance and mitigate risks.
- Collaborating cross-functionally to support regulatory aspects of clinical trial planning and execution.
Requirements
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of global regulatory requirements and guidelines for clinical trials.
- Proven ability to manage regulatory submissions and interactions with regulatory agencies.
- Excellent communication, attention to detail, and problem-solving skills.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsregulatory requirementsclinical trial planningcompliance monitoringrisk mitigation
Soft Skills
communicationattention to detailproblem-solving