Beschreibung
Regulatory Submission Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 7 MM+
Main tasks:
- This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials Phase 1 - Phase 4
- You will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team (CTA Working Group that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
- You will either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country
- You are responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
- You manage the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system
- If Clinical Research Organizations are contracted to handle some (or all) aspects as outlined above, you will be responsible for liaising with and overseeing CRO staff, as required
Main qualifications
- You have 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
- In-depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills
Main advantages:
- A very renowned company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Selma Hrustic
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