Position Overview
The Global Regulatory Compliance Manager is responsible for regulatory oversight of the Albaugh global supply chain, ensuring high quality from primary and secondary material sources.
The individual is also tasked with establishing standards and maintaining regulatory compliance efforts under the Albaugh Sustainability program umbrella.
The Global Regulatory Manager will be expected to support the work of the Global Regulatory Director for new product development and defense.
Principal Duties & Responsibilities
Lead and manage Regulatory aspects of the Global Supply Chain and Global Regulatory Compliance/Sustainability Efforts:
•Oversee strategic regulatory efforts regarding the Albaugh Supply Chain by interfacing withOperations and Legal, ensuring that product sourcing, sample acquisition, and samplehandling complies with all regional regulatory requirements and avoiding IP infringement.
•Provide technical expertise for technical specifications (5-batch analysis) to supportAlbaugh active ingredients to maintain compliant and equivalent sources by establishingand maintaining relevant purity limits and acceptable impurity profiles for technicalmaterials.
•Interface with the Formulations Director to ensure Formulation compliance, includingregional/local regulations on components and production compliance with registeredformulas.
•Lead strategic efforts for evaluating, maintaining, and ensuring global regulatorycompliance efforts to meet the Albaugh Sustainability Program objectives including highquality data generation for reporting and documented SOPs.
Establish a process for Grouplevel reporting.
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• Lead the Global Regulatory Compliance Initiative on behalf of Global Regulatory, including design and implementation of auditing process, training, SOP authorship and maintenance, and process improvements.
• Lead the Global SDS Consolidation effort such that it complies with requirements for SAP while meeting regional needs and standards.
• Oversee the performance of external consultants to support Supply Chain and Compliance initiatives.
• Effectively interface with allied functions, including Technology, Operations, and Legal.
• Effectively interface with supply chain and compliance experts in Regions.
• Travel to Global Regions (as needed) to meet with regional regulatory teams, regulatory authorities and consultants to support Albaugh defense and new projects.
Support the Global Regulatory Director as needed for the following responsibilities:
• Develop and implement global regulatory strategies to deliver rapid approvals and effective product defense with advantageous labels in keeping with the properties of the products and the needs identified by the Regional Markets.
• Support regulatory activities on current and future products across Markets; provide advice, consulting and problem-solving on registration matters, especially in your specific area(s) of expertise (e.
g.
, specifications, physical chemistry, 5 batch analysis, impurity profiles, compliance, e-fate).
• Provide training in your area of expertise where appropriate for the Regions.
• Assist in preparing regulatory budgets, forecasts and timelines.
• Represent Albaugh on industry task forces and groups as needed.
• Assist in providing guidance for prioritization of regulatory activities, balancing new product development with defense, compliance, and alternative source registration activities.
• Identify opportunities to improve efficiencies in regulatory activities and data development, including utilization of local resources (human and capital) in service of Group-wide objectives, and rational utilization of outside consultants and contractors.
• Assist in continuous improvement of a global data storage and retrieval global solution.
• Monitor data development to avoid duplicative, unnecessary data generation, identify potential extra-territorial impacts, and ensure appropriate sharing across regions.
• Support globalization of new product formulation development activities of Technology function
Other duties as required or requested.
Required Education and Experience
MS or PhD (preferred) in Chemistry, Biology, Agronomy, Biochemistry or related field
Minimum 10-20 years’ experience in crop protection chemical regulatory affairs
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