Regulatory Specialist

Posted 2 Days Ago
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Hiring Remotely in TN
Remote
Mid level
Healthtech • Pharmaceutical • Manufacturing
The Role
The Regulatory Specialist will manage product registrations and ensure compliance with regulations for animal health in North West Africa, mainly in Tunisia, Morocco, and Libya.
Summary Generated by Built In

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Regulatory Specialist

As a Regulatory Specialist, you will be part of the Regulatory Affairs team to deliver timely product registrations and renewals across North West Africa (mainly Tunisia, Morocco, and Libya). In this role, you will be responsible for managing the full lifecycle of product registrations and ensuring 100% compliance with local regulations for our animal health portfolio.

Your Responsibilities:

  • Manage the end-to-end registration process, including new submissions, renewals, and variations, while owning interactions with competent authorities in Tunisia, Morocco, and Libya.
  • Compile registration dossiers, arrange translations, and manage sample requests to ensure compliance with local regulations and the yearly registration plan.
  • Ensure regulatory compliance of printed packaging materials, label artworks, and promotional materials by reviewing and approving them in accordance with company processes.
  • Monitor and interpret changes in local regulatory requirements, providing accurate updates to internal stakeholders and identifying potential risks to mitigate gaps.
  • Collaborate with cross-functional teams to deliver projects on time and support other departments with accurate regulatory information and communication.

What You Need to Succeed (minimum qualifications):

  • University degree in Pharmacy or Veterinary Medicine.
  • A minimum of 3 years of experience in Regulatory Affairs within a local or international company.
  • Advanced fluency in French, English, and Arabic languages with a strong analytical mindset.

What will give you a competitive edge (preferred qualifications):

  • Demonstrated ability to set priorities and manage multiple tasks effectively.
  • Strong interpersonal and communication skills with a proactive approach.
  • Personal accountability and a strong drive for execution.
  • Disciplined and precise mindset regarding data and documentation.

Additional Information:

Travel: Minimal international business trips required

Location: Tunis, Tunisia.

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Top Skills

Animal Health
Regulatory Affairs
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The Company
HQ: Greenfield, Indianna
8,445 Employees

What We Do

At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives. Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society. Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco

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