Manager (m/w) Global Regulatory Darmstadt
On behalf of our client we are looking for support of the pharmaceutical department.
Your role
- assist the Global Regulatory Lead and/or the Regional Lead in preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical trials, marketing applications or other related regulatory submissions
- manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentations at different Regulatory milestones
- Manage regulatory agency interactions, document preparation, co‐ordination rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist).
- Review and provide regulatory comments to quality‐, safety‐ and efficacy or labeling related documents (e.g. protocols, reports) to be included in a regulatory submission (e.g. Clinical Trial Applications, IND, Scientific Advice, HA interactions, Answers to Authorities, PIP/PSP, ODD, DSUR
Who you are
- Degree in Life Science or related discipline, higher degree preferable (Pharm.D., MSc, PhD, MBA)
- Minimum of 5 years’ industry experience of which at least 3 years’ regulatory experience
- Solid knowledge of European regulatory procedures and requirements
- Experience in preparation and submission of a full submission/or large variation/supplement in at least one ICH region through to authorization
- Experience with regulatory agency interactions and preparation of documentation to support interactions
Haben wir Ihr Interesse geweckt? Dann bewerben Sie sich jetzt, wir freuen uns auf Ihre Bewerbung an Tom Sander oder https://www.recruiting-randstad.de/generator.php?id=629 . Für Rückfragen steht ihnen Tom Sander jederzeit gerne zur Verfügung.
Wir freuen uns darauf Sie kennen zu lernen. Good to know you!
Randstad Deutschland
P2 12
68161 Mannheim
T +49 621 1206942
www.randstad.de
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