Regulatory Affairs Business Partner in a growing pharmaceutical company responsible for registration procedures in the EU. Preparing documentation and collaborating with various teams for compliance and regulatory strategy.
About the role
- Regulatory Specialist ensuring compliance for plant protection products at Ascenza Agro. Collaborating with internal teams and regulatory authorities to manage registration dossiers and strategies.
Responsibilities
- 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., EC Regulation 1107/2009)
- Monitor and interpret relevant legislative updates, ensuring their correct application in internal processes
- Interact with regulatory authorities and monitor approval, renewal, and amendment processes for product registrations
- Collaborate with internal teams to ensure the technical and documentary compliance of product files
- Support the business with relevant regulatory information
- Manage electronic platforms and regulatory databases, ensuring the updating and integrity of information
- Support regulatory audits and inspections, providing necessary documentation and clarifications
- Contribute to the definition of regulatory strategies, anticipating risks and opportunities in the product lifecycle
- Provide technical support (and training, if necessary) to other team members, promoting good regulatory practices
- Participate in external and internal meetings representing the company and/or the regulatory team
- Participate in internal and external conferences and training sessions representing the company or the regulatory team.
Requirements
- Bachelor's degree in agronomic engineering, agricultural engineering, or equivalent fields (mandatory requirement)
- 1-2 years of experience in the role, preferably in the crop protection industry
- Knowledge of Regulation (EC) 1107/2009
- Strong written and spoken English skills (mandatory requirement)
- Ability to organize, plan, and take responsibility for assigned tasks
- Rigor and attention to detail
Benefits
- Integration into an enthusiastic and collaborative team
- Compensation and benefits based on position and experience
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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