EMEA Regional Submission Partner

Encontrado en: beBee S ES - hace 4 semanas

Spain Corteva Agriscience Teletrabajo Freelance A tiempo completo
225436W-01-4

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 submissionsServe as a focal point to ensure Submission Center dossier templates are available and fit for purpose for EMEA submissionsHelp establish interim and long-term solutions to overcome tool difficultiesAssist with the development and roll-out of Submission Center trainingsProvide training and guidance to EMEA colleagues on Submission Center principles, tools, processes, and business rules as requiredOversee 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 LeaderServe on the Transparency Regulation Intelligence and Implementation team and actively participate in activities/discussionsAssess 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 submissionsEnsure placement of IUCLID and study report redaction workWork 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 completionReview previous IUCLID submissions to drive suggestions for improvement to enable future successAct 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 workServe as EMEA subject matter expert acting as conduit between EMEA Regulatory and the Center of Regulatory Enablement (CORE) teamHelp onboard/mentor other future global Regional Submission PartnersAssist with global Submission Center activities where required
Qualifications

Required Skills and Qualifications:
BS degree in chemistry, biology, engineering, or related scientific field or Business/ IT field or equivalent experience is preferredPrevious scientific and/or regulatory experience is desiredPrevious EMEA Regulatory experience preferredProficiency in MS Office, especially Word and Excel (Macros/VBA a plus)Experience with Project ManagementAbility to learn and retain complex process flows and systemsHigh attention to detailStrong problem-solving skills both with identified issues and in risk mitigationUnderstands regulatory processes for life sciences and biotechnologyExcellent communication, organizational, and collaboration skillsAbility to work appropriately with all levels of global Corteva staffAbility to work effectively and independently in a fast paced/multitask environmentAbility to adapt to change appropriately and quicklyUnderstands protection of company intellectual property

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