ES European Regulatory Manager (m/f), Lyon

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Position Description

As a European Regulatory Manager, you achieve and defend registrations by managing and steering regional and country registration activities for new or existing active ingredients and their formulated products. The ERM is fully responsible for the regional registration process for a product portfolio based on 1 to 5 active substances.

Within this position, you will have to ensure the following tasks:

• To lead EU registration and re-registration processes for lead formulations in support of active ingredients registrations, new and existing products. In this frame, manage contact with EU risk assessors (RMS and Commission) in order to allow Region Europe to meet its short and long term business objectives in close cooperation with the ES-GRMs, Crop Development Expert departments or external consultants, while aligning Crop Protection, Environmental Science and Seeds, by using cross-functional and cross-regional networks.
• To define and implement the regulatory strategy at the European level, and to participate actively to the definition of the business strategy, and to advise product teams in achieving their Life Cycle Management and Product Defense goals for specific existing products (incl. investment and / or divestment decisions) and Time to Market/Peak Sales goals for projects (laid down in project plans),both by working closely with Portfolio Management, Development Functions, Region and Countries, providing regulatory expertise as required. Provide early warning to business on regulatory trends, decisions and possible business impact.
• To support the local (country) registration, defense and stewardship process through coordination and providing the technical expertise and generating the necessary data, in close cooperation with CRM and Crop /ES Development Expert Departments
• To drive the registration process; coordinate cross-functional processes (e.g. by participating in project sub-teams). Steer the compilation of high quality registration dossiers on time for major markets and all countries in Europe, in close collaboration with other development functions, and countries.
• To manage the planning, budget and execution of all non-core EU relevant studies in a timely and cost-effective manner through close contacts with Bayer Crop development experts to secure the timely registration of new formulations or line extensions and re-registration of our existing products or third-parties products.

Qualifications

• Master Degree in chemical and biological/health sciences including agronomy (such as PHD equivalence), you have a significant experience in a similar position. An extensive knowledge of the agrochemical industry and comprehensive experience of regulatory affairs is an essential requirement for this job (i.e in depth knowledge of relevant regulations and requirements for submission of regulatory applications). You also already experienced working and/or living in an international context.
• You must have a good broad understanding of all regulatory relevant scientific subjects (e.g. chemistry, toxicology, ecotoxicology, environmental fate, etc.).
• Managerial skills, commercial awareness, strong communication skills and the ability to work in a multi-functional environment are essential to meet business objectives.
• The ERM position requires leadership skills, such as persuasion, patience, understanding, diplomacy, listening skills, optimism and persistence in order to deal effectively with different types of personalities and cultures and to act as a competent representative of the company to external bodies and companies. You should have the ability of applying principals of precedents to new situation and anticipate how authorities / EU legislators would analyse relevant factors.
• This position also requires solid negotiation skills with regulatory authorities and Third Parties and a very high level of integrity.
• Diplomacy, efficient organizer, good planner and communicator are skills that do characterize yourself. Credibility and compliance towards authorities are essential.
• Fluent English is mandatory (one additional major European language would be a plus).