Beschreibung
Regulatory Submission Publisher (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Plan, coordinate, compile, publishe and submit regulatory applications, in compliance with health authority regulations worldwide
- Ensure documents are compliant with company standards, ICH, and other guidelines for incorporation into eCTD submissions using publishing and editing tools
- Develop and maintain knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs and biologics
- Participate in development and implementation of new systems, processes, or other relevant tools; e.g., user acceptance testing for publishing system upgrades
- Proactively share best practices within the department and cross-functionally; identify and communicate opportunities for departmental enhancements and efficiencies
Main qualifications
- Profound experience in regulatory affairs, pharmaceutical or biotech industry, publishing, and/or document management
- Associate or Bachelor’s degree in Life Science or business related field
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel), Adobe Acrobat, regulatory publishing software, and document management systems
- Excellent communications and organizational skills
Main advantages:
- We provide security – attractive salary, punctual payment, full social insurance, continued pay in case of sickness and during holidays
- A very renowned company
- We will create a candidate profile containing your strengths and potential and thus increase your chance of being placed in a position
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.
My contact at Hays:
My contact person:
Mihai-Lucian Burcea
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