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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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!

Associate Manager – Global Regulatory Services

Responsibilities:

• This position is within the Global Regulatory Services Team and supports global registration submissions of new and existing Animal Health Products by coordinating, preparing and/or delivering registration documentation, data, samples, and reference standards to the global affiliates and agencies. This is done in a timely fashion to support meeting critical registration timelines and is carried out in compliance with Elanco and Global Regulatory standards and guidelines.

Functions, Duties, Tasks:

Key Responsibilities include, but are not limited to:

• Coordinate affiliate requested product samples and reference standards for registration purposes
  • Understand analytical test methods and product specifications, calculate needed amounts and identify and order appropriate chemical substances
  • Effectively liaise between Supply Chain, Quality and regulatory affiliates to coordinate complex samples requests meet specified timelines
  • Proactively track and forecast samples needs
• Support affiliates globally by reviewing, coordinating, and/or fulfilling requests for regulatory documents
  • Initiate requests for government issued documents and prepare internally generated administrative documents
  • Route regulatory documents for signatures and legalization
  • Print, scan and ship documents to government agencies and global affiliates
• Negotiate with affiliates and government agencies around document types and document availability
• Manage the Elanco LOA/POA template library
• Participate in special projects which support increased efficiency and/or process improvement
• Other responsibilities, as assigned, to support overall Regulatory objectives and goals
• Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training
• Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

Key Attributes:

• Excellent organizational, project management, and time management skills
• Attention to detail
• Open, clear, and timely communication
• Strong interpersonal skills and ability to work effectively with cross-functional teams
• Understanding the customer needs to drive effective solutions.
• Demonstrated ability to negotiate solutions to complex technical challenges
• Ability to work in a virtual setting across different cultures and time zones

Minimum Qualification (education, experience and/or training, required certifications):

• Bachelor’s Degree, preferably in a health-related or scientific field or a minimum of 3 years' work experience in the pharmaceutical industry, drug development, or in regulatory affairs
• Advanced Chemical education/knowledge
• Prior Regulatory Affairs experience
• Fluent English

Other Information:

• Domestic and International travel may be required (less than 5% of the time).
• Additional languages are a plus

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