EMEA Biotech Zonal Regulatory Associate
Corteva
- Brussel
- Vast
- Voltijds
- 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
- Team of Biotech Zonal Regulatory Leaders, Biotech Regional Regulatory Manager
- Global Biotech Regulatory Sciences colleagues
- Team of Zonal Regulatory Associates
- 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
- 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
- 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.
- 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.