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Senior Officer Regulatory Affairs (US) (m/f) Job ID: 10400

Ihre Aufgaben
  • Work in coordination with the Manager Regulatory Affairs to defne and implement registration activities for company's products in defined region (US market)
  • Responsible for preparation, compilation, quality & scientific check and publishing of RRPs submissions for products in compliance with regulatory guidance/requirements in the defined region and company's internal standards
  • Ensure completeness and accuracy of submissions to regulatory authorities in support of assessment studies, market-specific regulatory engagement activities and existing marketing authorization
  • Stay abreast of current and new legislation in the defined region. Follow and analyze the applicable regulatory requirements in the region and contribute to the implementation of submission plans and strategies
  • Contribute to the development and implementation of processes, systems and tools enabling effective regulatory documentation/content management and communication with/submission to regulators
  • Provide input to optimize processes to ensure the development and implementation of electronic systems for effective management of documentation, submissions and archives
  • Provides technical advice to cross-functional project teams, as needed
  • One direct report (Officer Regulatory Affairs)
Ihr Anforderungsprofil
  • Preferably degree in Regulatory Affairs (e.g. graduate certificate in Regulatory Affairs), natural sciences (e.g. MSc) or medical speciality (e.g. Public Health, Pharmacist etc.)
  • 5-7 years’ experience in regulatory affairs with direct involvement in the preparation of Marketing Authorization Applications (MAA) in the USA
  • Dealing with ambiguity and accounting the environment where regulations are not mature, definitive or do not exist
  • Good understanding of applicable regulatory requirements and regulators mindset, the authorization process and structure of regulatory dossiers
  • Knowledge and practical experience with systems supporting the development and publishing of MAA and submissions
Auf Anfrage
Auf Anfrage
Dominik Reinelt
Fon +41 41 510 04 90
Mobil +49 152 338 598 09
Dominik Reinelt
Fon +41 41 510 04 90
Mobile +49 152 338 598 09
Mail dominik.reinelt@theentourage.ch
Betreff Bewerbung für Job ID 10400 auf theentourage.de