Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Senior Regulatory Affairs Manager (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in Hesse
Branche: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Work in-house within the Global Regulatory Affairs team and support the Global Regulatory Affairs team in the management of marketed products
- Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation (mainly Europe, Canada and Australia)
- Manage of the regulatory day-to-day agency interactions (mainly with EMA) and act as agency liaison for CTAs/INDs
- Liaise with functions in the Headquarter and the Regulatory Affairs units in countries
- Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs
- Represent Global Regulatory Affairs in project teams and clinical trial teams
Ihre Qualifikation
- Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
- Profound experience in Regulatory Affairs
- Experience with NCEs / NBEs (New Chemical Entities / New Biological Entities) products, one with device experience
- Experience with regulatory agency interactions and preparation of documentation to support interactions
- Knowledge in Therapeutic Areas Endocrinology, Fertility, Neurodegenerative diseases and Oncology preferable
- In depth knowledge of marketed product maintenance requirements in Europe (PSURs, renewals, CMC and labeling variations) familiar with International requirements
- In-depth knowledge of European regulatory pathways (CP, DCP/MRP, national procedures)
- Experience in preparation and management of Clinical Trial Applications to major European and International health authorities
- Experience with Life- Cycle- Management activities in at least two regions (among them Europe ), i.e. ability to prepare regulatory strategies for LCM projects
Skills:
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- Drug regulatory affairs manager
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager