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Regulatory Expert (m/w/d)

Referenz: 414799001900

on 05 August 2020
Stadt
Frankfurt/Main
Vertragsart
Festanstellung

The future belongs to those who drive innovation, inspire transformation and fuel collaboration. Our commitment is achieved by working together with our clients in combining the key technologies IT, Engineering and Life Sciences in order to develop innovative solutions for the future. We connect top companies with the sharpest minds in Life Science. All of them united by their burning passion to make use of their talents in order to master the challenges ahead. Are you one of them?

If so, you are what we are looking for as a co-worker for a project by one of our customers, a renowned company in the pharmaceutical Branche, located in Frankfurt am Main, Industriepark Höchst. Commencing immediately, on a temporary basis.

What you can do for us

Regulatory Compliance:

  • Supports batch release by following submission and approval to ensure the product regulatory compliance
  • Ensures that the CMC dossier is in line with manufacturing and control procedures and with dossiers approved by Health Authorities
  • Contributes to site inspections and audits
  • Supports product licenses maintenance and site registration
  • Reviews and signs-off documents like SOPs or technical reports

Change Control:

  • Assesses and manages change control activities with regulatory impact for the site
  • Provides regulatory expertise to site projects
  • Manages regulatory activities linked to change controls including updating of the CMC files

CMC Documentation Management:

  • Supports Marketing authorisations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by writing and approvi
  • Optimizes the content of CMC dossiers to facilitate the management of future changes
  • Writes ready for submission CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions and supports CMC writing performed
  • Prepares with contribution of site experts answers to questions from Health Authorities

The skills that are needed

  • Ph.D or Master in a science/health field (e.g. Mathematic, Chemistry, Pharmacy, Biology, Biotechnology Sciences etc.) or equivalent
  • Knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends is perferrable
  • 2-5 years of direct Regulatory CMC experience is preferred
  • Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable
  • Experience of manufacturing operations, Biotechnologies, Biological products is a plus
  • Capability of resolving strategic technical and regulatory issues
  • Should demonstrate initiative, independent thinking, anticipatory foresight
  • Strong communication skills
  • Business level in German and English (written & spoken)

Why you are in the right place when working with us

We connect the right professionals with the right project, as we do by connecting you with our recruiting projects! Our path together begins with trying to comprehend your ambitions. We shall work together to help you achieve your career objective, by investing in your professional development and mentoring, and by coaching you throughout your career. Modis is a global leader in professional solutions and a dynamic brand with a global focus. We are pursuing ambitious goals in a key market. Our affiliation with Adecco Group opens up a wide array of career choices for you.

You can hardly wait to get to know us? Then a simple click will quickly connect you with us. Just click on "APPLY NOW“ to send us your application.

Your Contact

Frau Laura Mäntele

Bewerbung.FreiburgLS@modis.com

Modis GmbH

Life Science

Güterhallenstraße 4

79106 Freiburg

Phone +49 761 3890 8216

www.modis.com

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