Emea Regulatory Manager Small Molecules and

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**EMEA Regulatory Manager Small Molecules and Biosolutions (W/M) - STA of 12 months**

**EMEA Regulatory Manager Small Molecules and Biosolutions (W/M) - CDD of 12 months**

**Purpose**

With an adapted product portfolio, achieve and defend registrations by managing regional and country registration activities for new formulated biological products especially. Propose and implement regulatory strategies to optimize the value of specific active ingredient(s) and product(s).

Based on his/her knowledge of the regulatory arena, the EMEA Regulatory Manager (ERM) is the key interface between Regional Marketing and Field Solutions to provide regulatory input and leadership necessary to align the needs of the business and the Development functions to succeed in a process-oriented organization. He/her can oversee 3rd Party Products registration activities. And he/she can be responsible of Supply Security work (EMEA & FR Site change).

The ERM co-operates with Regulatory Authorities, through regional and country networks, thereby shaping the reputation of Bayer as a leader in the biological regulatory arena and ultimately achieving registrations for new products and safeguarding those for existing ones according to business objectives.

While this is principally a regional role, the ERM is working in partnership with the Global Regulatory Manager for asset and product registration activities.

**Key tasks**:

- 1/ With an adapted product portfolio and some oversight and guidance, being responsible for proposing and implementing the EMEA regulatory strategies for specific EMEA biological formulations and EMEA biological asset in collaboration with the GRM.
- 2/With some oversight and guidance, should manage the development and registration process of 3rd Party biological products; coordinate cross-functional processes if/when needed. Steer for the compilation of high-quality registration dossiers on time for important biological markets and assigned countries in EMEA, in close collaboration with other development functions, and countries. Manage the planning, budget and execution of necessary regulatory studies in close contacts with development experts (and GRM) if needed especially for a new asset. With some oversight and guidance, identify and initiate all necessary studies to secure the registration of new formulations or third parties’ products.
- 3/ Provide input to product/project teams in achieving their Time to Market/Peak Sales goals for projects (laid down in project plans) by working closely with EMEA Portfolio Management, Development Functions, Region, and Countries. Collect advice on the implementation of any stewardship activities necessary to obtain/defend authorizations of products and in promotion of their sustainable use. Give input on registrability or regulatory consequences, costs, timelines, and prioritization issues in order to facilitate decisions on investments for assigned Project/Products/certain formulations, line extensions etc.). The ERM provides information for into decision meetings at regional and global level for his/her active substance/product portfolio.
- 4/ Contributes to the approval of biological active substances in the EU all along the process. He/she particularly contributes to the selection of representative formulations and the respective use pattern. Evaluates the risk and impact of any authority decision on the authorization of products in the countries. Contributes (in close cooperation with the GRM) to the definition of the best regulatory strategy. Manage the preparation of dossiers necessary to control a danger to plant health in close cooperation with Product Development. Being responsible for registration of formulations within the EU and/or assigned countries in EMEA, according to the Zonal approach including preparation, coordination, submission of the dossier and managing contacts with the different Zonal Rapporteur Member State(s). With some oversight and guidance, the ERM is responsible for collating the relevant GAP information (Good Agricultural Practice) This will normally be achieved through close co-operation with experts, Country Regulatory Managers, Market Segment and development teams.
- 5/ Support the local registration, defense and stewardship process by coordinating the technical expertise and generating the necessary data in close cooperation with the count