Onsite Regulatory Expert

Posted 3 days ago

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About the role

  • 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

Job title

Regulatory Expert

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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