Regulatory Affairs Manager

Job location: Cracow
Ref no.: SEL/077

 

Key responsibilities are:

Your main role will be providing medical or disease area expertise to clinical projects or trials within defined therapeutic areas for the timely preparation and execution of the clinical development program, in particular:

  • Ensure optimal acceptable regulatory strategies for worldwide compliance and submissions
  • Provide regulatory perspective and leadership to multiple project teams
  • Author and compile FDA and Ex-US regulatory applications and submissions
  • Lead preparations for meetings with regulatory agencies to ensure efficient drug development
  • Oversee external vendor to ensure on-time preparation and publication of regulatory submission documents in coordination with the Regulatory Operations function
  • Identify relevant and emergent guidance documents and international standards – provide interpretive guidance and ensure guidance is implemented into development planning and execution
  • Communicate with regulatory agencies regarding submission strategies and potential regulatory pathways
  • Prepare information or responses as requested by regulatory agencies
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
  • Ensure regulatory documentation is maintained appropriately 

 

Your background should include:

  • PhD or MD with at least 5-8 years of experience in regulatory affairs
  • Regulatory state-of-the-art medical knowledge of assigned area
  • Familiar with all aspects of regulatory processes with different authorities like the FDA and EMA such as fast track, breakthrough designation, PRIME, etc.
  • Experience with face to face meetings with the FDA and EMA
  • Ability to write scientific documents
  • Knowledge of GCP and world-wide regulatory requirements relating to assigned area
  • Excellent presentation and communication skills
  • Analytic and leadership skills
  • Fluent English

 

As standard You will receive benefit package, which consists of:

  • Work in a team of highly-qualified and experienced professionals
  • Opportunity for rapid career development
  • Participation in challenging and ambitious projects
  • Package of benefits: private medical healthcare, Multisport Card, lunch subsidies, days with fruits, language classes refund
  • Possibility to take part in sports activities
  • Access to attractive infrastructure: fitness and spa zone in the building
  • Work in a dynamic Company with high perspective of growth and operating in innovative business sector

 

If you are interested please send your CV to career@selvita.com with subject line SEL/077 REGULATORY AFFAIRS MANAGER

 

We kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Selvita S.A. for the purpose of existing recruitment process”.

If you want us to keep the submitted documents also for the purposes of future recruitment processes, we kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Selvita S.A. for the purpose of future recruitment processes for a period of 3 years from the date of submission of this document, in order to analyze them in terms of the recruitment processes carried out in the Selvita Group”.