Regulatory Operations Leadership Position
hace 1 semana
Company Overview: ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, welcoming talented professionals to join our mission in shaping the future of clinical development.
Salary: We offer a competitive salary ranging from $150,000 to $180,000 per annum, commensurate with experience.
Job Description
We are currently seeking a Director, Regulatory Operations to lead our diverse and dynamic team. As a key member, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Key Responsibilities
- Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
- Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
- Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
- Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
- Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.
Requirements
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of global regulatory requirements and guidelines.
- Proven track record of successful regulatory submissions and approvals.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
- Proven leadership experience.
Benefits
We offer a range of benefits designed to support your well-being and work-life balance, including:
- 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 future.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of specialized professionals.
- Lifetime assurance.
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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