EMEA Biotech Zonal Regulatory Associate

Corteva

  • Brussel
  • Vast
  • Voltijds
  • 1 maand geleden
DescriptionCorteva Agriscience has an exciting new position for an EMEA Biotech Zonal Regulatory Associate (m/f/d) located in Europe, preferably in Brussels, Belgium but open to other locations where Corteva Agriscience has an office.This is an excellent opportunity to join a global R&D based company with market leading positions in both crop protection and seeds and a strong commitment to the discovery and development of new technologies to meet the needs of a growing world population.Purpose:
  • Provides registration support to a Biotech Zonal Regulatory Leader for new biotech traits and renewal projects, with a strong focus on EU.
  • Provides hands-on and technical support to develop and manage regulatory dossiers for the European Food Safety Authority.
  • Supports dossier submissions, monitoring trends, archiving, and documenting
  • Supports on EU Transparency requirements, notifications, and redactions
  • Plays a proactive role in identifying opportunities for improvement of tools and processes
Interacts with:
  • Team of Biotech Zonal Regulatory Leaders, Biotech Regional Regulatory Manager
  • Global Biotech Regulatory Sciences colleagues
  • Team of Zonal Regulatory Associates
Key Responsibilities:
  • Support Zonal Regulatory Leader in defined, delegated tasks and activities for biotech approval projects, actively using the company tools and data management systems. For example:
  • Participation in project team meetings to coordinate applications in line with regulatory requirements and respond to questions from authorities
  • Support in the execution of project plans
  • Assembly of regulatory data and management of progress tracking tools
  • Updating of dossier templates in line with latest regulatory intelligence
  • With Zonal Regulatory Leader, review dossier sections for accuracy and completeness, ensure applications and processes meet internal Corteva standards
  • Preparation of submission documents for biotech dossiers.
  • Support for literature review exercises
  • Maintenance of comprehensive documentation records - databases and file shares
  • Supports notification of studies, redactions, monitoring of websites
#LI-OB1 #LI-HybridQualificationsQualifications and Skills:
  • Educated to at least BSc level in a biological science, preferably with an additional higher level scientific degree. Background in Molecular biology, plant genetics, plant biotechnology is a plus
  • Previous work experience with regulated products is desirable
  • Strong communication skills, proactivity, agility, self-motivated, attention to detail and well-organised - but also must be an effective team player and self-starter
  • Highly proficient in MS office (especially Word and Excel)
  • Highly proficient in written and spoken English
Who Are We Looking For?
  • Curious, bold thinkers who want to grow their careers and be part of a winning team.
  • Market shaping colleagues who want to transform the agriculture industry to meet the world's growing need for food.
  • Collaborators who thrive in a diverse, inclusive work environment.
  • Innovators who bring initiative and fresh ideas that drive our business into the future and make us an industry leader.
Growing What Matters Starts With You… What We Can Offer To Help You Grow?
  • Opportunity to be part of a global industry leader working to discover solutions to the most pressing agricultural challenges of our time.
  • Stimulating work assignments that grow your skills, capabilities and experiences.
  • Opportunities for international rotations and relocation that will expand your global view and cultural experience.
  • Diverse, inclusive work environment where employees bring their whole selves to work and feel heard, valued and empowered.
  • Dedicated and customized resources to help grow your professional skills, industry expertise and personal perspectives.
  • Joining us is a natural opportunity to strengthen your professional network through valuable relationships.
  • Support the health and well-being of every employee by offering world-class benefits, meaningful work and competitive salary.
  • Performance driven culture with a strong focus on speed, efficiency and agility.

Corteva