Regulatory Specialist

SUMMARY:

A well-established leading agricultural solutions provider specialising in crop protection products, plant nutrition, and sustainable farming innovations for global markets is seeking the above to be responsible for developing and implementing regulatory strategies, maintaining compliance with local and international regulations, and managing audits, inspections, and product submissions. This role also involves training staff, providing regulatory guidance across departments, and ensuring timely and accurate communication with regulatory authorities.

POSITION INFO:

Minimum requirements for the role:

• Must have a Degree in Horticulture/ Plant Pathology/ Chemistry/ Entomology or a related field
• SACNASP registration or candidacy is required
• Minimum 3-6 years’ experience in a similar role
• Excellent written and verbal communication skills as well as the ability to work comfortably under pressure and meet tight deadlines
• Must have strong decision-making and problem-solving skills

• Developing and maintaining regulatory standard operating procedures.
• Training staff in regulatory policies or procedures.
• Maintaining current knowledge of relevant regulations, including proposed and final rules.
• Managing activities such as audits, regulatory agency inspections, or product recalls.
• Participating in the development or implementation of clinical trial protocols.
• Directing the preparation and submission of regulatory agency applications, reports, or correspondence.
• Formulating or implementing regulatory affairs policies and procedures to ensure that regulatory compliance is being maintained or enhanced.
• Providing regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Communicating regulatory information to multiple departments and ensuring that information is being interpreted correctly.
• Developing regulatory strategies and implementation plans for the preparation and submission of new products.
• Implementing or monitoring complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Investigating product complaints and preparing documentation and submissions to appropriate regulatory agencies as necessary.
• Monitoring emerging trends regarding industry regulations to determine potential impacts on business processes.
• Overseeing documentation efforts to ensure compliance with domestic and international regulations and standards.
• Representing the business before domestic or international regulatory authorities and/or agencies on major policy matters or decisions regarding company products.
• Reviewing all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Reviewing materials such as marketing literature or user manuals to ensure that regulatory agency requirements are being met.
• Contributing to the development or implementation of business unit strategic and operating plans.
• Establishing procedures or systems for publishing document submissions either in hardcopy or electronic formats.
• Serving as the primary contact and source of sound, practical, and reliable scientific information in order to provide opportunities for the company and its customers.

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