Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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