Regulatory Manager DACH Region

Role purpose

Regulatory leadership of assigned products in DACH (Germany, Austria, Switzerland) to ensure delivery of the portfolio objectives in line with agreed business strategies.

Accountabilities

• Obtain and maintain product authorizations in DACH in line with agreed business objectives through:
  • Effective management of relations and communication with Member State regulatory authorities and internal EU Regulatory team.
  • For new products collaborate with Regional Regulatory Managers (RRM)/ on dossier preparation (technical sections: physico chemistry, analytical methods, toxicology, residues, environmental fate and ecotoxicology), review sections and ensure that local requirements and risk assessments are considered and correctly performed.
  • For existing products, ensure the maintenance of the existing portfolio, guarantee all national requirements/timelines to keep existing products in the market in line with business objectives. Collaborate with RRMs on the renewal dossier preparations. Review sections and ensure that local requirements and risk assessments are considered and correctly performed. Manage the administrative prolongations.
  • Support RRM in completing the pre-submission work and presentations to official authorities.
  • Effective partnership with relevant teams (R&D and Marketing) to represent regulatory and safety positions and facilitate business decisions.

• Maintain freedom to operate by coordinating and carrying out administrative tasks related to changes in formulation and origin of manufacture. Coordinate all administrative/technical procedures: submission of post-registration demand, applications for second trade names, changes in terms of conditions of use, changes of composition, change of company or factory address/name, comparative evaluation.
• Follow up on the registration application submitted: check admissibility. Active participation addressing data gaps identified and commenting tables, all this in collaboration with the RRM and the consultant.
• Participate and cooperate in the country portfolio strategy in collaboration with local Marketing and R&D Departments. 
• Coordinate the submission and completion of application of minor uses.
• Coordinate PCN/UFI files with the European compliance team.
• Check the country SDS from the European Compliance team.
• Ensure compliant labelling, in accordance with regulatory authorisations and local packaging and labelling legislation and manage all aspects of label creation and documentation in both internal and external mandatory databases.
• Maintain and share a strong knowledge of European and national legislation and activities which could impact national and zonal existing or future approvals of Plant protection products / Biocides.
• Represent the company in front of the Authorities
• Ensure regulatory and technical watch. Helps to improve the quality of registration dossier communicate local requirements.

Knowledge, experience & capabilities

Critical knowledge

• Scientific background enough to review risk assessments.
• Good understanding of regulatory processes in EU and DACH countries

Critical experience

• Regulatory experience in the EU (5-year experience minimum)
• Experience in dossier preparation and Risk assessment
• Negotiation and advocacy skills

Critical technical, professional and personal capabilities

• Effective time and task management to ensure delivery of the business needs
• Delivery of quality work even under time pressure
• Ability to manage complex issues without being the expert in any one discipline
• Effective team worker
• Openness and willingness to challenge the accepted ways of working and to implement new ones
• Good communicator

Critical leadership capabilities

• Active management of the workload
• Willingness to try new approaches
• Performance driven, with a 'can-do' attitude.

Critical success factors & key challenges

• Detailed knowledge of relevant regional regulations and adjacent legislation
• Regulatory foresight to proactively manage arising issues
• Perseverance to ensure regulatory success
• Fluent in English and German in technical discussions and advocacy