Beschreibung
Regulatory Data Management Associate in EMEA RMC (m/f)
Reference: -en
Start: asap
Duration: 9 MM+
Main tasks:
- Responsible to cooperate with RMC Submission Management, Labelling Management and LOC respective RA staff on label changes and CMC variations
- Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status
- Perform specialized activities in the submission process for all countries within their cluster or even region including:
- Data and record management (ie timely preparation, completion and approval of country records, archiving relevant submission and approval documents, closing record)
- Ensure compliance/audit readiness within own tasks considering all applicable - procedural documents.
- Constant updates of records documenting
- Give inputs on internal processes improvements, database projects, updates and implementations
- Assesses the impact of current regulatory requirements on the business to assist in the development of innovative Regulatory strategies and/or innovative ways to execute them
- Responsible for all RA Databases (including but not limited to InSight/GRAIL/SPS/Trackwise)
- Manages multiple and changing priorities based on factors such as time constraints, urgency, and business need
Main qualifications
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Regulatory experience with exposure to EMEA regulations, submissions and variations
- Previous experience with InSight/GRAIL/SPS/Trackwise
- Fluency in English is required
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.
My contact at Hays:
My contact person:
Selma Hrustic
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