About this role
About the Role ICON is seeking a Senior Manager, Regulatory Strategy to oversee regulatory affairs operations for global clinical trials, shaping regulatory strategy and ensuring compliant, timely submissions. You will design and analyse clinical development programs, translating complex data into regulatory pathways.
What You'll Do
- Develop and implement regulatory strategies for global clinical trials.
- Provide expertise and guidance on regulatory requirements and compliance issues.
- Collaborate cross-functionally with teams to meet regulatory objectives.
- Lead interactions with regulatory agencies and prepare submissions.
- Keep abreast of regulatory updates and industry trends to inform strategy.
What We're Looking For
- Bachelor's degree in a relevant scientific discipline or healthcare-related field.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong knowledge of global regulatory requirements and guidelines.
- Proven track record of successful regulatory submissions and interactions.
- Excellent communication, leadership, and problem-solving skills.
Compensation & Benefits
- Competitive salary; benefits include annual leave entitlements, various health insurance offerings, and retirement planning.
- Global Employee Assistance Programme, LifeWorks (24-hour access to a global network of professionals).
- Life assurance; flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others).
- ICON is committed to inclusion and equal opportunity and provides an accessible environment for all candidates.