Regulatory Expert responsible for product registration and regulatory compliance at ASCENZA in Portugal. Collaborating with national authorities and managing regulatory dossiers and strategies.
Responsibilities
Responsible for the product registration in her/his geographies directly or via consultancy
Prepare/manage the submission and monitor the evaluation of regulatory dossiers for the registration of plant protection products, ensuring compliance with national and European regulations (e.g., Regulation EC 1107/2009)
Define together with the Global Regulatory Manager the registration strategy for it’s geographies
Acting as direct contact person with Ministry and or distributors and other registration services in the countries of his/her responsibility
Support and guarantee alignment of national consultants when applicable
Advise and support Global regulatory manager, Product safety department and business with critical information regarding the national laws, guidelines and regulations
Collaborate with Global Regulatory manager in setting and controlling product registration Budget
Ensure compliance of MSDS and Labels for product registered on the market
Follow-up of the competitor’s registration activity
Ensures database updating for his/her geographies
Ensure Anti poison center notification when applicable
Represents ASCENZA in the regulatory teams in the industry association when required
Participate actively in internal or external meetings, workshops, trainings
To provide technical support (and training, if necessary) to other team members, promoting good regulatory practices
Is responsible of specific Projects eventually assigned by the Global Regulatory Manager
Requirements
University education in agricultural sector, agronomic engineering, agricultural engineering, or equivalent areas (mandatory requirement)
Graduation on Plant Protection field to comply with the National dossier submission requirements to act on behalf of the company (plus)
Minimum 3 years of relevant work experience in plant protection products registrations in country/region
Knowledge of Regulation (EC) 1107/2009
Knowledge of Regulation for Plant Protection Product Norms (EU and national level)
Professional proficiency in English, both spoken and written.
Benefits
Integration into an enthusiastic and collaborative team
Compensation and benefits based on position and experience
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