Biobest Group is developing and significantly growing its biopesticides portfolio. The development program of plant protective products requires regulatory stewardship to manage the applications and submissions process, as well as reviewing and giving regulatory advice on due diligence of 3rd party products.
At Biobest we are hiring a Regulatory Manager Biopesticides. He/she will coordinate all the stages of regulatory submissions, primarily in the EU, but also in specific territories outside of the Union. The Regulatory Manager Biopesticides will work with CRO’s and consultants to ensure a registration plan for all products is in place and all legal requirements to sell a product are being fulfilled.
Functie omschrijving - Regulatory Manager
Purpose of the position
As Regulatory Manager Biopesticides, you are responsible for managing the ‘Active Substance Submission’ for several entomopathogenic fungi. You prepare strategies, obtain quotations, and manage the various phys-chem, tox and efficacy requirements, for the subsequent ‘Product Registrations’ that are expected as outputs. You liaise closely with the Business Development Team, to ensure that the product label is relevant and that the appropriate information is shared as input for the business case.
- You support Biobest’s product portfolio needs to various authority bodies through participation in such initiatives as the IBMA.
- You engage with external consultants involved in supporting specific regulatory needs and evaluate quotations.
- You coordinate the ongoing regulatory process for active substance and product registrations.
- You support the Development Team in the selection of product excipients to ensure both regulatory compliance and that the product is commercially usable.
- You support the Business Development Team with costings and timelines for the preparation of business cases.
- You assist with regulatory processes such as EUPs, Basic Substance applications and emergency exemptions.
Functie eisen - Regulatory Manager
What do we expect from you?
- Proven experience in managing registration processes in a crop protection setting, in both the UK and the EU.
- Excellent planning and budgeting skills.
- The ability to communicate complex plans to an audience with a mixed level of regulatory understanding.
- Weekle visits to Biobest Headquarters in Belgium.
What can you expect from us?
- Biobest Group gives you the opportunity to make a significant impact to a more sustainable horticulture.
- Our joint efforts achieve double-digit annual growth, and we retain a continuous focus on sustainability as well as social responsibility initiatives.
- Your position offers strong collaboration with external stakeholders and colleagues worldwide as well as a wide variety of responsibilities.
- A close-knit team, each with their own domain of expertise, ensures a great atmosphere and a winning mentality.
- You will receive an employee contract with a competitive salary package, supplemented with extra-legal benefits such as a hospital and group insurance, meal vouchers and eco vouchers.
Interesse in Regulatory Manager?
Sounds like you?
Please respond by sending your resume with cover letter to firstname.lastname@example.org