Regulatory Affairs Leader
5 days ago
We are seeking a highly skilled Regulatory Affairs Leader to join our team at ICON plc in Gauteng, Johannesburg. This is an exciting opportunity for a seasoned professional to lead and oversee regulatory operations activities ensuring compliance with applicable regulations and guidelines.
Key Responsibilities:
- 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.
Compensation: The estimated salary for this role is R1,200,000 per annum, depending on qualifications and experience. We offer a competitive benefits package that includes medical aid, retirement funding, and life insurance.
About ICON plc: As a leading contract research organization, we are committed to advancing human health through innovative clinical trials. Our team of experts provides cutting-edge services to pharmaceutical and biotechnology companies worldwide.
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