Regulatory Affairs Specialist CTA

04 May 2021
25 May 2021
Beata Klecz
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Regulatory Affairs Specialist Clinical Trials Application- 9 Months contract

We have an exciting opportunity for a Regulatory Affairs Specialist with prior background in submission of Clinical Trials Application globally.

Your responsibilities:

You will be responsible to provide input into global regulatory strategy for early development compounds.
You will contribute to regulatory innovations (e.g. novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways).
You will contribute to identification of regulatory issues, gaps, affecting optimal and timely submission and approval.
You will be a key contributor in the core project Teams to the overall project development strategy.
You will work in a high-performing multi-disciplinary Team to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator

What you'll bring to the role:
A Science based BS or MS with requisite experience and demonstrated capability. Scientific curiosity is a nice-to-have in this role. Advanced degree (MD, Ph D, PharmD) is a plus. Fluent English (oral and written) as a business language.
2-4 years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge and regulatory operational expertise of EU regulatory affairs. Additional knowledge of other regions is an asset.
Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline, as well as with biologics is an asset.
Strong interpersonal, communication, negotiation, problem solving skills and ability to work in a global/matrix environment.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.