Regulatory Submissions Manager
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Job Description
Manager, Regulatory Affairs contributing to drug development as part of the Regulatory Affairs team at ICON plc. Providing regulatory guidance and operational support across various stages of drug development.
Responsibilities:
- Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
- 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
- Must have experience overseeing preparation of core regulatory packs for Canada
- Experience in Companion diagnostics, IVDR submissions, clinical performance studies is preferred.
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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