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Emea Regional Submission Partner

Il y a 4 mois

Guyancourt, France Corteva Temps plein

**Description**:** GROWING WHAT MATTERS STARTS WITH YOU**
Corteva Agriscience, the world's first dedicated agriculture start-up, serves to enrich the lives of those who produce and those who consume, ensuring progress for generations to come. Our employees fulfill this purpose everyday by building/participating in an inclusive culture where we encourage each other to stay curious, think differently, act boldly and do what's right for our customers, our co-workers, our partners and our planet. With over 20,000 team members from 130 countries, innovating in 140 world class R&D facilities, we have the resources, leadership heritage and partner ecosystem to make a meaningful impact now and into the future.

**#GrowWhatMatters**

**Purpose**:
The EMEA Regional Submission Partner is responsible for providing critical support for important, and often time-sensitive, business needs such as activities associated with essential regulatory submission requirements. This work will involve the use of our Submission Center Tool, our EU IUCLID tool, as well as our EU Data Transparency activities. This position will work closely with the Submission Center Product Owner to provide training, work through change management communications, and provide improvements to our tools and processes.

**Key responsibilities**:
Submission Center Activities
- Coordinate with EMEA Regulatory Affairs colleagues to ensure the successful creation of submission packages that meet the regulatory needs in time for submissions
- Serve as a focal point to ensure Submission Center dossier templates are available and fit for purpose for EMEA submissions
- Help establish interim and long-term solutions to overcome tool difficulties
- Assist with the development and roll-out of Submission Center trainings
- Provide training and guidance to EMEA colleagues on Submission Center principles, tools, processes, and business rules as required
- Oversee backfill and population of data in preparation of upcoming selected submissions in EMEA to ensure full utility of Submission Center

EU Data Transparency/General Food Law (GFL) Activities
- Serve as EU Transparency Regulation Implementation Leader
- Serve on the Transparency Regulation Intelligence and Implementation team and actively participate in activities/discussions
- Assess and adopt current tools and processes to ensure Corteva delivers transparency-compliant dossiers

IUCLID Activities
- Drive and coordinate the completion of IUCLID work for internal submissions
- Ensure placement of IUCLID and study report redaction work
- Work with key stakeholders to develop internal processes for future submissions to enable CRO (Contract Research Organization) work and implement within the relevant teams providing continued support through to submission completion
- Review previous IUCLID submissions to drive suggestions for improvement to enable future success
- Act as focal point for upcoming submissions, providing training, guidance and support as needed on both Submission Center and IUCLID to relevant regulatory teams

General Support Activities
- Serve as active project lead/member in all current and future project teams relating to EMEA Submission Excellence work
- Help onboard/mentor other future global Regional Submission Partners
- Assist with global Submission Center activities where required

LI-OB1 #LI-Hybrid

**Qualifications**:** Required Skills and Qualifications**:

- BS degree in chemistry, biology, engineering, or related scientific field or Business/ IT field or equivalent experience is preferred
- Previous scientific and/or regulatory experience is desired
- Previous EMEA Regulatory experience preferred
- Proficiency in MS Office, especially Word and Excel (Macros/VBA a plus)
- Experience with Project Management
- Ability to learn and retain complex process flows and systems
- High attention to detail
- Strong problem-solving skills both with identified issues and in risk mitigation
- Understands regulatory processes for life sciences and biotechnology
- Excellent communication, organizational, and collaboration skills
- Ability to work appropriately with all levels of global Corteva staff
- Ability to work effectively and independently in a fast paced/multitask environment
- Ability to adapt to change appropriately and quickly
- Understands protection of company intellectual property