Description
Regulatory CMC (m/f)
Reference: -en
Start: 01/19
Duration: 6 MM++
Main tasks:
- Regulatory transmission: Act as single point of contact and advisor for worldwide regulatory intelligence information on the site
- Coach, train and develop the site’s personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information
- Change control: Support the site in generation of effective change control strategies
- Verify regulatory relevance of changes - includes performing regulatory pre-evaluation of changes
- Submission support: Support the CMC documentation preparation by facilitating timely provision of good quality source documentation, involving co-authoring as applicable, and accurate comments from technical experts to RA CMC
- Health Authority Responses: Provide on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA)
- Regulatory Compliance: Support and address issues related to regulatory compliance checks
Main qualifications
- Requirements: At least profound experience of RegCMC and production experience
- University degree in relevant field
- German and English skills
Main advantages:
- Fascinating, innovative environment in an international atmosphere
- You will work in an international environment
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:
Eden Lara Gordon
Referencenumber:
Make contact:
Email: