Eastman Regulatory Affairs project mgr Crop Protection BE in Ghent North, Belgium
We are seeking a candidate with knowledge and skills to support product solutions in the crop protection specialties market. The candidate will work in the Global Crop Protection, Product Stewardship and Regulatory Affairs (PS&RA) organization. The position closely collaborates with business and technology managers, product stewards, and product registration/clearance and hazard communications personnel supporting existing products, and the development and commercialization of new products.
Tasks and responsibilities:
• Manage effectively crop protection projects for active substance and formulated products in Europe and provide direction and leadership to the project expert teams.
• Acquire in-depth knowledge of relevant end points, studies, risk assessments and registration dossiers with regards to the existing portfolio of active substances and end-use crop protection products.
• Advise our crop protection product stewardship and regulatory affairs (PS & RA) team, as well as the business and technology groups with effective strategies that support the regulatory defense of our existing portfolio, in addition to the development and registration of new compounds/products.
• Work closely with Eastman legal staff and/or contracted regulatory consulting companies. Negotiate with stakeholders (project team, sponsors, contract research organizations, labs and consultants) the specific needs in terms of lab and field toxicology studies, proposing the best solutions (scientific design in line with guidelines, deadlines, quality assessment of the suppliers, costs) and to ensure the timely review and approval of study plans.
• Assure the scientific, budgetary and temporal follow-up of all studies under your responsibility in order to achieve the negotiated objectives, costs and deadlines. Attention for detail and being able to critically review (draft) study reports is a must.
• Able to interpret study results and to present conclusions and rationale to Regulatory officials and other audiences, as needed.
• Prepare position papers and data waivers, evaluate endpoints, and coordinate risk assessment of PPP's with external stakeholders.
• Able to develop/maintain a sound awareness of regulatory & testing guidelines (GLP) for all types of Crop Protection related studies.
• Hands-on crop protection product registration experience in certain countries or geographies, and willing to take an intra-regional registration coordination responsibility in collaboration with the RA Team and the local PSRA colleagues. Ability to work independently for the preparation of registration applications. Prepare supporting documents, follow-up on submissions & local testing, and providing regulatory expertise.
• Participate in advocacy and product stewardship initiatives. Represent Eastman in trade associations and subject matter consortia.
Strong candidates for this position should have many of the following skills, or be willing to be trained in these areas.
• The position requires a Master degree in Chemistry, Bio-Engineering, Life Sciences, Toxicology, or related-scientific field with a preference for specialization in plant protection or crop sciences. A PhD/Doctorate in a related-scientific field would be an asset.
• At least 5 years of experience in pesticides regulatory affairs in fields such as toxicology, ecotoxicology, E-Fate, residues, and/or product registrations.
• Good comprehension on Procedures for the Approval of active substances and authorization of plant protection products in the EU. Overview of worldwide registration processes or ability to assimilate the regulatory guidelines quickly is an asset.
• Steady knowledge of new and developing guidance documents in one of the expert fields.
• Work on different projects simultaneously;
• Work effectively in a team and matrix organization together with other regulatory and scientific subject experts;
• Translate complex scientific topics into comprehensible key messages for different audiences;
• Engage effectively with authorities, customers, industry groups and other stakeholders;
• Communicate fluently, both written and orally. Positive and supportive attitude is a must;
• Travel occasionally in Europe and other geographies of interest;
• Speak and write fluent English is mandatory for the position. Understanding and speaking Dutch is highly recommended. Other languages such as German, Spanish, French or Italian are an asset.