Regulatory Submissions Manager – EU CTR
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Job Description
Regulatory Affairs Manager at ICON overseeing submissions across EU and UK for drug development. Leading regulatory activities and providing support within a cross-functional team environment.
Responsibilities:
- Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA EU CTR and UK-specific submissions essential experience here required
- Management of activities associated with obtaining initial, amendment and other central authority approvals
- Companion diagnostics, IVDR submissions, clinical performance studies experience would be beneficial
- Oversee preparation of core regulatory packs.
- Provide broad regulatory support across EU and UK requirements.
- Provide regulatory guidance and efforts to internal teams
- Participate in agency interactions and regulatory submissions
- Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
- Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature
Requirements:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
- Prior experience with various regulatory submissions, including CTA/IND/MAA
- Ability to lead internal teams and carry out regulatory activities independently
- Strong understanding of global regulatory requirements and guidelines
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.
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