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Senior Regulatory Development Specialist

2 meses atrás

Lisboa, Lisboa, Portugal Elanco Tempo inteiro

About Elanco

At Elanco, we are a global leader in animal health dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.

We pride ourselves on fostering a diverse and inclusive work environment where diversity is the driving force behind innovation, creativity, and overall business success.

Making animals' lives better makes life better – and we're looking for talented individuals like you to join our team

Job Description:

The Senior Regulatory Development Specialist will play a key role in developing and implementing regulatory strategies for new and existing products. This includes leading cross-functional teams to ensure compliance with relevant laws and regulations.

This position requires a deep understanding of the pharmaceutical development process and the ability to foster molecules from concept through approval and data-driven life cycle management.

The ideal candidate will have a strong background in regulatory affairs, experience working with the animal health industry, and knowledge of the animal drug development process.

Main Responsibilities:

  • Develop and implement global regulatory strategies for new and existing products
  • Lead cross-functional teams to ensure compliance with relevant laws and regulations
  • Collaborate with Marketing, Research and Development Teams to develop and maintain draft launch labels
  • Prepare and maintain text-based mock labels to inform commercial labeling throughout the development process
  • Design and develop creative global regulatory strategies and technical regulatory documents based on interpretation of both regulatory and scientific information
  • Knowledge of and compliance with relevant laws and regulations, and global policies and procedures
  • Maintain a positive business collaboration and partnership with regulatory authorities
  • Serve as a resource to development teams and the commercial organization to actively address informational needs, including global and regional promotional material review

Requirements:

  • Masters degree or higher within the sciences, degree in veterinary medicine or equivalent experience
  • Regulatory Affairs experience
  • Understanding of the animal health industry and the animal drug development process

Salary: $110,000 - $130,000 per annum (dependent on experience)

Location: [Varies]