This is a new hire for a global pharmaceutical company who have a footprint in nearly every major city across the globe.
In this role, you will be pivotal in leading and driving proactive RA strategy for the assigned compounds, from early & late-stage development molecules. A hybrid setup is on offer. You will have oversight of the below activities:
Responsibilities:
* Marketing authorization applications
* Clinical trial (& Ethical Committee) applications and amendments
* End of study notifications, clinical study report & safety summaries
* Scientific advice meeting briefing packages
* EMA Scientific advice/attendance at FDA meetings (to support at the request of MTPA RA) & protocol assistance requests
* Orphan Drug Designation & Paediatric Plans (PIP)
* Answers to regulatory questions working with
* Provides the EU Development and submission strategy
Requirements:
* Minimum of a Bachelor's Degree in Life Sciences
* Extensive regulatory experience in pre and post marketing
* Breadth of knowledge and experience in clinical development through to submitting for approvals (MAA), which will include NDA/BLA/CTA.
* Several years of experience in interacting with EU and US regulatory agencies.
* Knowledge of EU MDR/US Medical Device Regulations.
Seniority level
Director
Employment type
Full-time
Job function
Science, Manufacturing, and Product Management
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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