Director, Regulatory Operations

Job title : Director, Regulatory Operations
Job Location : Gauteng, Johannesburg

Deadline : December 15, 2024

Quick Recommended Links


Jobs by Location
Job by industries

What you will be doing 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.
Your profile 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

Pharmaceutical  jobs