Please apply in English, applications in other languages will be rejected
GFIC
recruits for an international Flavours and Food Ingredients company the
Director for Regulatory Compliance, Quality Assurance Flavours and Food Ingredients m/f/d Location remote: Any in Europe. Required frequent travelling within the subsidiaries
JOB PURPOSE:
• The purpose of this role is to define strategy and take a proactive leadership to coordinate all strategic and operational activity on Regulatory and Quality at Group level.
• The role involves defining, aligning and implementing Group standard policies, procedures, and practices to ensure that the company operates with a global approach in accordance with applicable laws, regulations, and quality standards. This includes coordinating the risk assessment activities and the remediation plans.
• By effectively managing compliance and risk, the candidate will leverage regulatory and quality strategies to actively contribute to business development by helping the company to gaincompetitive edge, expand into new markets, enhance customer satisfaction while optimizing operational efficiency.
• The candidate's role will be also crucial to assist the Group in
deploying a PLM System (HAZEX/DEVEX) to standardize our ProductInformation, drive standardization process for Raw Material, product development
processes, inter-company authorization flows, shared documentation repository.
o Identifying opportunities and threats in the regulatory landscapes and support the group on this topic in the Mergers and Acquisitions.
• Quality Assurance: Drive standardization, centralization and digitalization of the Quality Assurance activities carried out by the group's local teams, with a particular attention to organizational and operational synergies on Quality management Systems compliance, Auditing and continuous improvement.
TasksKEY RESPONSIBILITIES:
• Standardize Group approach and set, implement, oversee global regulatory and quality strategy, with attention to organizational and operational synergies and cost optimization.
• Continuously monitor and interpret changes in regulations, standards, and industry guidelines to ensure the organization remains compliant with global regulatory requirements in alignment with
corporate goals.
• Oversee the creation, maintenance, and submission of regulatory documentation required for product approvals, licenses, and certifications including plants audits.
• In line with the business strategy, set and implement the overall Regulatory and Quality mission and strategy. Check that each local Regulatory and Quality department follows it in line with locallegislation.
• Auditing: Oversee internal audits and assessments activity.
• Regulatory Affairs Support: Collaborate with product development teams to navigate regulatory
pathways, streamline approvals, and expedite product launches.
• Proactively identify regulatory risks to company's programs and develop risk mitigation plans
creating a process for identifying, and quickly remediating risks and/or compliance
concerns/issues. Ensure quick escalation of significant legal, quality, and regulatory issues or concerns.
• In line with the corporate goals, define, develop, and manage Global Regulatory Affairs and QA
RequirementsQUALIFICATIONS & EXPERIENCE • Minimum of 15 years of chemical/biotech/pharmaceutical leadership, with a proven leadership to design and build from scratch a global Regulatory and Quality organization needed to achieve company objectives (direct experience on Flavours and Colours regulatory legislation will be a plus).
• Proven knowledge of PLM systems to manage Regulatory and Product Development in the chemical or food industry, especially Hazex/Devex systems.
• Broad and deep regulatory agency knowledge and experience interpreting and guiding application of global regulatory requirements across multiple sites; Extensive exposure with multiple regulatory agencies.
• Ability to build and maintain effective internal and external relationships, including with local cross-functional teams, individual contractors, contract research organizations, external associations and other vendors to effectively manage all legal, regulatory and quality related activities.
• Proven ability to analyse complex issues to quickly address key issues for discussion with regulatory authorities and guide teams (internally/externally) in the preparation of responses to regulatory questions.
• Demonstrated and extensive hands-on attitude on the field to deliver goals.
• Team builder able to engage local Quality, Regulatory departments to encourage collaboration.
• Excellent written and oral communication skills and the ability to effectively communicate with
internal and external team members on project activities.
• Fluent in English, French or Italian is a plus.
• Ability to travel up at 50%.
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