Head of Regulatory and Technical Ssa

2 days ago

Durban, South Africa Mayfly Agri (Pty) Ltd Full time

**Minimum requirements for the role**:

- Must have an M.Sc. in Agricultural Sciences
- Must have a CropLife Basic Crop Protection certificate
- A post-graduate business qualification will be an advantage
- 10 to 12 years experience in Project Management for technical product development and regulatory compliance will be required
- 4 to 5 years experience in managing a reporting team is essential
- Must have the ability to organize, manage and develop a multifunctional team
- Expert knowledge of product development methodology as well as all guidelines and regulations required for compliance under Act 36 of 1947 for crop protection chemical is important
- Above average knowledge of major crops and their associated disease, insect and weed control requirements is essential
- Must have a basic understanding of business finance and business legal processes and requirements
- Guiding concept development to be inclusive of all requirements for successful product registrations.
- Setting and monitoring the budget and project time lines to deliver all biological and regulatory data as agreed.
- Building strong and sustainable relationships with well performing CRO''s and laboratory services to ensure that company requirements are dealt with as priority.
- Promoting a culture of continuous improvement through training to keep abreast of advances in crop, product and R&D technologies.
- Ensuring proactive involvement of Regulatory with the development process to acquire and /or initiate studies in support of a successful and complete submission.
- Facilitating interaction with Marketing, Supply Chain and Production to manage formulation and source changes to maintain regulatory compliance.
- Fostering an environment wherein the regulatory team members can function in a self-directed manner and building knowledge networks to fully contribute to the compliance and product development processes.
- Promoting a culture of continuous improvement through training and following changes in the local and global regulatory frameworks.
- Conducting and coordinating activities to investigate and report on circumstances and probable causes.
- Triggering any required external services to broaden investigation.
- Informing and involving legal and insurance as required.
- Using all facts and evidence to make a logical and fair conclusion on causes of complaint.
- Implementing the required processes ensuring protection of existing IP, internally and externally.
- Conducting FTO analyses on new developments for the region and provide technical input if and when new developments are deemed patentable.
- Fulfilling and complying with requirements dictated by development and supplier contracts.
- Seeking advice and complying with legal requirements to not prejudice the company with respect to product performance claims and settlements.
- Engaging with lawyers, insurers and assessors in resolving product performance claims.
- Participating in global projects regarding technical advice and alignment.
- Setting function objectives, monitoring progress and providing support and guidance to ensure the required targets are met on time.
- Setting and monitoring processes to manage continuous compliance with laws and regulations.
- Ensuring formulation and source compliance, and optimizing formulations and changes to enhance regulatory compliance.
- Developing new formulations.
- Following changes in regulations and addressing technical queries in support of submitted dossiers.
- Agreeing on third party development needs and managing associated projects. Providing regulatory support and facilitating daughter registration contracts where relevant.
- Defining Marketing and Commercial development needs and communicating progress.
- Managing product performance complaints.
**Salary package is highly negotiable depending on experience gained.

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