Offer summary

Qualifications:

Bachelor’s Degree in a health-related or scientific field or 3 years of experience in the pharmaceutical industry or regulatory affairs., Advanced knowledge in chemistry is required., Prior experience in Regulatory Affairs is essential., Fluency in English is mandatory, and additional languages are a plus..

Key responsibilities:

Coordinate and prepare registration documentation and samples for global registration submissions.

Liaise with Supply Chain, Quality, and regulatory affiliates to meet sample requests and timelines.

Track and forecast sample needs while supporting global affiliates with regulatory document requests.

Manage the Elanco LOA/POA template library and participate in process improvement projects.

Job description

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

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