Regulatory Analyst
hace 2 días
**Regulatory Analyst**
**Position Summary**:
The Regulatory Analyst supports the Regional Regulatory Manager in overseeing product registrations, ensuring compliance with regulatory standards, and facilitating the approval process for new and existing products. The role involves detailed analysis, coordination with internal teams, and the preparation of documentation required for regulatory submissions. The Regulatory Analyst works closely with the Regulatory Assistant and collaborates with cross-functional teams to ensure timely and accurate regulatory processes.
**Location**: Flexible
**Reports to**: Regional Regulatory Manager
**Assignment Date**: Full-Time
**Essential Duties and Responsibilities**:
- ** Regulatory Documentation**: Prepare and submit regulatory documentation for new product approvals, re-registrations, and label amendments, ensuring compliance with regional and local regulations.
- ** Compliance Management**: Monitor and ensure compliance with local and international regulations, including labeling, safety, and promotional materials.
- ** Coordination and Communication**: Work closely with the Regulatory Assistant and other team members to manage regulatory timelines and ensure effective communication of regulatory requirements across departments, including marketing, R&D, and supply chain.
- ** Data Analysis**: Analyze data from various sources, including scientific reports, regulatory guidelines, and product testing results, to support the regulatory submission process.
- ** Regulatory Strategy**: Assist the Regional Regulatory Manager in developing regulatory strategies and pathways for product registration and market entry across multiple regions.
- ** Submission Tracking**: Maintain detailed records of regulatory submissions, approvals, and ongoing projects. Monitor progress and report to the Regional Regulatory Manager on key milestones.
- ** Liaison with Authorities**: Coordinate with local regulatory authorities, as well as internal teams, to address regulatory queries, provide additional information, and resolve issues as they arise.
- ** Cross-functional Collaboration**: Collaborate with the Regulatory Assistance and cross-functional teams to ensure all regulatory processes are aligned with business goals and market needs.
- ** Database Management**: Maintain and update internal regulatory databases, ensuring accuracy and timely reporting of regulatory data and statuses.
**Education**:
- Bachelor’s degree in a relevant scientific field (e.g., Chemistry, Biology, Agronomy, or a related discipline).
- Advanced degree preferred but not required.
**Experience / Skills / Abilities**:
- Minimum of 2-3 years of experience in a regulatory or compliance-related role, preferably within the agrochemical, pharmaceutical, or crop protection industries.
- Strong understanding of regulatory frameworks and processes in regional or global markets.
- Experience with regulatory submissions and managing product lifecycles.
- Strong analytical skills and the ability to interpret technical data and regulatory requirements.
- Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint, with the ability to manage data and prepare reports.
- Excellent verbal and written communication skills in English; additional languages are a plus.
- Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.
**Job Expectations / Working Conditions**:
- Ability to work collaboratively in a fast-paced, team-oriented environment.
- Flexibility in working hours to accommodate different time zones for global cooperation.
- Ability to travel occasionally to meet with regulatory authorities or attend industry events.
- Comfortable working in an office setting, with regular interaction with internal and external stakeholders.
This position offers the opportunity to develop regulatory expertise while contributing to the growth and success of the organization in a dynamic, global industry.
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