Regulatory Affairs Specialist, Southern Africa at Monsanto Company

Job description

Job Purpose

Co-ordinate all aspects of regulatory affairs for respective country, countries or sub-region, in close collaboration with the Africa Asia regulatory team, delivering and maintaining regulatory approvals in accordance with business strategy for our crop protection, traits and conventional seeds portfolio; developing internal awareness of the local rules and regulations relevant for our business, working on regulatory policy matters impacting the business; supporting effective stewardship of the company products in the region. .

Responsibilities

• Contribute to the introduction of biotech products in focus countries in CES through the preparation and submission of trial applications; effectively supporting and ensuring compliance during in-country trials, preparing and submitting a commercial application, supporting the review process through effective communication with regulatory authorities and stakeholders as required, working towards approvals of products and commercialization of biotech in key countries
• Support the Regional Lead with providing the regulatory support required to register new varieties in Africa on National and Regional variety lists by co-ordinating the application processes Support the global seed movement operations through assisting with the provision of regulatory expertise Support the Regional Lead with obtaining and maintaining crop protection registrations; keep track of portfolio registration status; coordinate and compile registration renewal submissions, new submissions (products, uses) and review/ update product labels as needed. Liaise with and ensure timely communications and responses to regulatory stakeholders in order to secure and maintain our regulatory FTO. Ensure compliance for all CP activities requiring regulatory support.
• Effectively communicate policy and legislative developments (internally) which could have an impact on FTO in the region. Work closely with the regulatory policy lead to develop supportive relationship with various stakeholders and regulatory authorities and positively influence policy development creating FTO in accordance with business strategy
• Engage with stakeholders and regulatory authorities on the harmonization of seed and biotech regulatory systems and regional approvals
• Support the stewardship of our products by ensuring compliance with legislation, guidelines and permit conditions. Work closely with third parties, as required, to ensure that trials managed by third parties are managed in a manner that ensures compliance with external and internal stewardship requirements
• Maintain electronic archive of all regulatory correspondence, applications and approvals
• Develop skills which can assist in career development and growth within the company
• Comply with the company health and safety requirements
• Ensure compliance with internal business conduct and maintain the high professional reputation of Monsanto

Required Skills/Experience

• MS in Biology, Molecular Biology, Chemistry, Genetics or related field of study.
• Excellent written/oral communication and organization skills.
• Strong project management skills.
• Ability to organize data and information effectively.
• Ability to write clear and convincing documents.
• Ability to work with customers to meet timelines and needs.
• Effective negotiation and persuasion skills.

Preferred Skills/Experience

• Experience with the regulatory approval process for biotechnology products.
• Experience interacting with key global regulatory governing bodies/agencies.