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Regulatory Affairs Manager Traits Emea

Il y a 5 mois

Diegem, Belgique Bayer Temps plein

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Regulatory Affairs Manager Traits EMEA**

The purpose of this role is to
- Ensure regulatory approvals for Bayer Crop Science´s (BCS) biotechnology products in accordance with the respective EMEA legislations, while protecting approvals for existing ones according to business objectives.
- Develop and implement regulatory strategies for individual products ensuring regulatory compliance throughout launch and commercialization.
- Address critical LTO issues pro-actively and reactively in collaboration with EMEA Regulatory Science clusters and Scientific Affairs teams.
- Represent and defend the interest of BCS in relevant industry associations and/or working groups.

**YOUR TASKS AND RESPONSIBILITIES**:

- Prepare, submit and manage high quality scientific dossiers according to global project plans, in compliance with relevant regulatory requirements and legislations.
- Keep abreast of latest scientific and regulatory developments and stay up-to-date with the latest developments in science and relevant legislation and guidance.
- Work closely with all stakeholders within and across functions to ensure necessary studies are available to secure the authorisation of new products and defend approved products, in a timely fashion.
- Develop and maintain current knowledge of EU/EU-MS and ex-EUMS regulations and establish working relationships with key regulatory authorities, reporting new developments that may impact BCS products and participate in problem solving that may reduce regulatory impacts and costs.
- Ensure professional contacts with relevant industry associations on global and local priority issues, promoting science-based approaches and global harmonization to regulatory issues.
- Work effectively with 3rd party contractors supporting regulatory submissions and post-approval compliance obligations.

At Bayer Crop Science we know that every field, crop and farmer is different. We offer tailored solutions that enable local farmers to grow smarter by developing crops that are resistant to environmental challenges and helping farmers defend their crops against weeds, diseases, harmful insects and fungi. Using the creative spark that comes from human ingenuity, we seek to deliver word-class innovation, set new standards in sustainability and drive digital transformation. Protecting harvests and fostering biodiversity, that’s how we shape the future of agriculture. Do you want to be an ally in our ambitious mission?

**WHO YOU ARE**:

- PhD or MS in plant science, biology, agronomy, biotechnology, environmental science (or related fields)
- Effective organizational and planning skills with an eye for detail
- Excellent communication skills (verbal and written) in English
- Influencing and leadership skills - able to develop collaborative relationships with various stakeholders both internally and externally
- Team player

**WHAT BAYER OFFERS YOU**
As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning. We offer our employees a wide range of career prospects, a modern working environment and competitive compensation. Bayer employees benefit from great employment conditions, such as:

- An excellent competitive salary
- Vacation allowance, meal vouchers, year-end premium and bonus (based on company results)
- Laptop, company car and smartphone
- In this position you have the choice to work in a hybrid setting, working 2 days or more in the office and the other days from home. If you work from home, Bayer will provide an office chair, laptop stand, USB keyboard, USB mouse, cabled headset, external monitor and USB extender, as well as a monthly internet provision of €20;
- net (as of 60% a desk will also be provided).
- 34 days of leave (20 legal days, 12 work time reduction days and 2 Bayer days)
- Group insurance which contains a defined contribution pension plan, life insurance and disability plan, hospitalization insurance, travel insurance and bicycle lease plan
- An inspiring working environment with professional and committed colleagues
- A successful innovative organization with international career possibilities
- Challenges and possibilities to learn and to develop

**INTERESTED IN THIS VACANCY?**

LI-BNL

**YOUR APPLICATION**

Do you want to work in a place where you can be just YOU?

Your unique personality, bac