Senior Regulatory Affairs Specialist

Are you ready for a new beginning?

We need your talent, knowledge and dedication to better our world with biology.

Our purpose points the way

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 we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.

We’re here to better our world with biology.

SENIOR REGULATORY AFFAIRS SPECIALIST

Animal and Plant Biosolutions – Middle East and Africa

Location: Istanbul, Turkey; Hybrid position

Scope of Work:

• Geographical reach: Middle East and Africa
• 50% animal and 50% plant dedication

Countries to support: Scope of Middle East and Africa. Preferred experience in: Turkey, Saudi Arabia, Egypt, Algeria, Pakistan, Kenya, or Nigeria

GENERAL SUMMARY:

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

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Defining safety and regulatory requirements for direct fed microbials and enzymes used in animal feed.
• Define regulatory requirements for microbial and microbial-derived 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, SharePoint, and SAP, 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 Turkish and English fluently. Proficiency in Arabic or French is a plus. Ability to effectively communicate both in oral and written form. Possess a basic understanding of regional animal food, pesticide, and fertilizer law and regulations in Middle East and African countries. Minimum of a Bachelor’s degree in a scientific or technical area such as microbiology, biology, chemistry, animal science, or plant pathology, or equivalent. Minimum experience 3-5 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.
Want to learn more?
Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com
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