Regulatory Affairs Specialist

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In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how weve gotten so far. And it’s how well impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.
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REGULATORY AFFAIRS SPECIALIST
Plant Biosolutions – Middle East-Africa
Scope Of Work

• Geographical reach: Middle East and Africa (with focus on Turkey, Morocco, Algeria, Egypt, Kenya, Nigeria, S. Africa)
• Languages: English, Arabic
  

General Summary
This position works under general direction and is primarily responsible for responding to internal and external inquiries related to the company’s plant biosolutions products and the regulations governing them in various countries of Middle East and Africa.
Principal Duties And Responsibilities

• Define regulatory requirements for microbial and microbial-derived products for use as fertilizers/biostimulants and pesticides.
• Defining safety and regulatory requirements for microbials and enzyme products for use as fertilizers/biostimulants and pesticides.
• Securing market access for biosolutions by preparing and submitting dossiers, and obtaining relevant licenses, registrations, and import permits.
• Communicates with government agencies on a regular basis regarding regulatory compliance of our products and processes.
• Working with relevant trade associations and government agencies on developing/defining regulatory pathways when unclear or path does not exist for microorganisms and microbial-derived products.
• Defines the optimum route to market, assesses risk, and secures that our products & associated promotion material comply with applicable legislations in targeted countries.
• Researches and prepares timely and accurate responses to customer inquiries regarding the regulatory status of products and certifications.
• Assists in the operation of systems, including Veeva and SharePoint and procedures to ensure timely and accurate data collection, maintenance and delivery of consistent regulatory information throughout the organization.
• Monitors regulatory changes affecting company products and communicates to appropriate inter-company stakeholders.
• Provides review of formulations and labels to ensure regulatory compliance in country of manufacture and sales.
  

Knowledge, Skills & Abilities

• Ability to read, write, and speak English and Arabic fluently is required.

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• Proficiency in other local languages spoken in the above noted countries is a plus.
• Ability to effectively communicate both in oral and written form.
• Possess a basic understanding of regional pesticide and fertilizer law and regulations in the above noted countries.
• Minimum of a Bachelor’s degree in a scientific or technical area such as microbiology, biology, chemistry, plant pathology, or equivalent.
• Minimum experience 2-4 years in regulatory role.
• Willingness to travel, domestically and internationally up to 20%.
  

Could our purpose be yours? Then apply today!
At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.
Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability, or veteran status.
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Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com
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