Regulatory Clinical Trial Application Submission
This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning five therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease).
The Regulatory Clinical Trial Application submission manager has experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.
Successful candidates for this position have:
- In depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.
- Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required
- The ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry. An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.
For the right candidate, the client has assured that after the initial on-boarding period, some remote working will be possible.
Plesae contact me for further details or to apply.
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