Hays

Regulatory Affairs Stragetist (m/w/d)

Berlin | Anstellung bei der Hays Professional Solutions GmbH
Referenznummer
508325/1
Startdatum
sofort
Meine Aufgaben
  • Contributes to the development of local regulatory project goals fromdevelopment through life cycle
  • Participates in the preparations for meetings and teleconferences With local HA officials
  • Works with Lead GRS and supervisor to compile and submit IND and Clinical trial applications to enable timely start of the clinical
  • Trials for the assigned development products.
  • Works with Lead GRS and supervisor to develop submission materials
    for local HA, guides the review process, checks for accuracy,
    scientific consistency, compliance to local HA regulations and
    completeness of submission
  • Collects, reviews and analyzes competitor information, local Agency
    guidelines and precedence Keeps abreast of changes in the local
    regulatory environment for the project
  • Contributes to the development of the Briefing document for the local
    authority meeting for assigned projects
  • Responsible for entering submission material and other documents and
    relevant data into appropriate RA databases
  • Where applicable, reviews external and internal communications on
    local level for regulatory accuracy and local HA compliance
  • May act as the primary interface between Bayer and the local Health Authority (HA)
  • May be involved in decision making on key development questions
  • May participate in ad hoc Global Project Team subteams or working
  • Groups as invited by the Global Project Team
  • May participate in a global regulatory team (GRT) and provided local
    regulatory input into the global development plan for assigned project

Meine Qualifikationen
  • Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life scienceswith direct experience in biomedical research activities.; orMS with of experience in biomedical activities; or BS of experience in biomedical activities
  • Basic knowledge of local Health Authority (HA) regulations (FDA or EMA) to support filings
  • Basic understanding of drug development (PK, PD, statisticalconcepts, data collection, endpoints, etc.)
  • A thorough knowledge of company policies and procedures in drugdevelopment and product maintenance requirements 
  • Good communication skills, verbal and written, are required 
  • Ability to work within a global team framework
  • Strong analytical skills are required
Meine Vorteile
  • Betreuung im gesamten Bewerbungsprozess
  • Betreuung im laufenden Projekt durch unser Team
Über Hays
Mit über 15 Jahren Erfahrung in der klassischen Pharmaindustrie ebenso wie in der Biotechnologie und Medizintechnik kennen wir die entscheidenden Ansprechpartner, die anspruchsvolle Aufgaben mit Potenzial ausschreiben. Die hohe Personalnachfrage eröffnet spannende Möglichkeiten für engagierte Experten, um sich beruflich zu entwickeln und an ihrer Karriere zu arbeiten. Ihnen als Kandidat bieten wir dabei als spezialisierte Personalberatung mit einem internationalen Netzwerk entscheidende Vorteile – und das völlig kostenfrei für Sie. Registrieren Sie sich und profitieren Sie von interessanten und passenden Positionen und Projekten.
Mein Kontakt bei Hays

Referenznummer
508325/1

Kontakt aufnehmen
Telefon: + 49 621 1788-4297
E-Mail: positionen@hays.de