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Regulatory Affairs Associate
1 week ago
Job Title: Regulatory Affairs Associate
Job Location: Walton Oaks
Job Duration: 6 Months
Key accountabilities:
• Participate in project teams to define country regulatory requirements
• Prepare accurate regulatory submissions to secure timely approvals in support of business initiatives
• Monitor the development of relevant changes to regulations and standards and communicate potential business impact to all appropriate levels of management
• Support training on local and regional regulatory requirements to the appropriate business team members and highlight implications of differences with respect to product development, testing activities and business strategies to minimise business impact and bring speed to the registration process
• Conduct training seminars on regulatory requirements and/or impending regulations to the appropriate business team members to enable the best global development activities
• Maintain regulatory procedures to ensure consistent, efficient and compliant regulatory processes
• Maintain tracking information in support of regulatory compliance for products with a food contact claim
• Communicate appropriately with all customers, government and regulatory agencies and peers, conducting all communications and transactions with the utmost integrity and honesty
The main challenges of the position are:
• Understanding the various domestic and international business needs and leveraging these against regional and country registration requirements.
• Understanding and interpreting domestic and international regulations relative to new technology and product development.
• Having the ability to understand the technical aspects of the vast array of regulated products manufactured and/or marketed by the client business units.
• Have the insight to problem-solve proactively on regulatory and associated quality issues.
• Comply with Client policies, internal controls and global regulations.
Personal attributes/key behaviours
Detail-oriented and strong organisational skills to handle multiple projects, the ability to work well under pressure, good oral and written communication skills and good interpersonal skills. The ability to demonstrate judgment, function as a cooperative team member, organise workload and setting priorities are essential.
Qualifications/Education/Experience Required:
A Bachelor´s degree, ideally in technical or scientific discipline and 2-3 years of relevant technical experience,
Experience should include close working relationships with Business, Marketing, Manufacturing and Research functions, and a solid background of technical knowledge and experience combined with the proven ability to successfully support projects.
Must be fluent in English, other languages are desirable.
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