Regional Regulatory Manager

4 giorni fa

Bergamo, Italia FMC AGRO POLSKA SP. Z O.O. A tempo pieno

**About us**

We, FMC Agricultural Solutions, provide innovative crop protection solutions to growers around the world. Thanks to the commitment of our 5,200 employees, we are one of the six largest crop protection manufacturers in the world.

For any FMC office located in EU we are looking for a

**Regional Regulatory Manager (m/ f/ d)**

As a Regional Regulatory Manager (RRM), you will lead the management, strategic planning, and coordination of regulatory projects across the EMEA region. In this role, you will be responsible for overseeing regulatory activities related to active substances and/or products. This includes working within Product Registration Teams (PRTs), collaborating with external consultants, business units, and support functions to ensure the delivery of high-quality regulatory submissions—on time, within budget, and targeting key markets.

Beyond project execution, the RRM will play a key role in the development of new products and contribute to shaping the business strategy for their assigned project portfolio.

**What you'll do with us**:

- Maintain a comprehensive overview of submission and approval timelines for assigned active substances and related products across the EMEA region.
- Manage day-to-day regulatory activities and assigned projects, ensuring alignment with internal priorities and timelines.
- Collaborate cross-functionally with portfolio managers to develop and implement registration strategies for new and existing products, within budget and deadlines.
- Identify and communicate regulatory risks and opportunities, providing clear updates to internal stakeholders and contributing to issue management planning.
- Prepare and maintain regulatory dossiers, position papers, and responses to regulatory authorities, including rebuttals and higher-tier data justifications.
- Represent FMC in interactions with regulatory authorities, EU institutions, and industry groups to support portfolio development and regulatory advocacy.

**Your qualification & attributes**:

- 8-10 years of experience in regulatory affairs, preferably, within the agrochemicals with a strong focus on the EMEA region.
- In-depth knowledge of national regulatory requirements and EU regulations, including Regulation (EC) No. 1107/2009, Regulation (EC) No. 396/2005, and related technical guidance.
- Strong understanding of regulatory processes, including higher-tier studies, risk assessments, and scientific justifications for data waivers or refinements.
- Proven track record in planning, coordinating, and delivering complex regulatory submissions, including budgeting and resource allocation within an R&D environment.
- Excellent project management and organizational skills with the ability to manage multiple priorities and deadlines.
- Clear and confident communicator with experience presenting regulatory issues and trends to internal stakeholders and engaging with regulatory authorities.
- Demonstrated ability to work effectively in cross-functional and multicultural teams, with a collaborative and solution-oriented mindset.
- Proficiency in maintaining regulatory documentation and internal databases in accordance with company policies and procedures.

**Are you ready to make an impact?

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