As an associate of Global Scientific & Regulatory Affairs, the Senior Specialist SRA performs a variety of scientific and regulatory activities to ensure compliance globally of raw materials. The role also supports SRA business processes, standards and systems development, deployment, and continuous improvement through metrics. This position partners with R&D, IT, Commercial, Corporate teams to provide regulatory support for these activities. This position proactively monitors the regulatory environment relevant to the business, analyzes the business impact, and takes action as appropriate to mitigate risk.
Essential Duties and Responsibilities:
- Leads global ingredient review process, including maintaining databases with key regulatory information and documentation on ingredients to ensure compliance in products worldwide.
- Supports the company’s global ingredient harmonization activities, and supports regionals SRA in the preparation and submission of technical documents, dossiers and petitions to regulatory bodies and governments in order to gain the approval of ingredients
- Coordinates global SRA change management program for ingredient, formula, and packaging
- Support the improvement of regulatory functions in the recipe system and drive harmonized global business processes
- In collaboration with regional SRA subject matter experts, build a strategic framework of future systems configuration
- Deep understanding of business needs and external SRA environment to develop and drive necessary activities related to key topics important to the company as a strategic partner for regional SRA associates and business stakeholders on key technical topics.
- Proactively monitors and interprets existing and proposed regulations, conducts risk and opportunity assessments, and proposes clear recommendations to the business.
- Provides critical support and leadership to SRA Standards impacting SRA.
- Represents the company position on external trade associations and committees.
- Serves as a regulatory resource for external suppliers and internal partners, including R&D, Legal, Commercial, etc. to address regulatory questions/issues.
- Provides support to quality processes and Quality Management Process (QMP) principles