Regulatory Affairs Associate - Product Development

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Through the application of scientific training, regulatory acumen, and relevant experience, the incumbent will have a deep understanding of the overall pharmaceutical development process and be able to foster a molecule from a product concept through the development process to approval and data driven life cycle management (LCM) evolution for Safety and Efficacy (S&E).

Functions, Duties, Task:

• Comprehension of and contribution to scientific components (existing data and literature) and how it relates to regulatory strategy globally
• Understand and evaluate a proposed product concept to provide the best possible product for the customer and increase Probability of Technical Success (PTS)
• Collaborate with New Product Value Analysis (NPVA), Research and Development Teams, and Global Marketing to develop and maintain draft launch labels (DLL)
• Prepare and maintain text based Mock labels to inform commercial labelling throughout the development process
• Design and develop creative global regulatory strategy (e.g., submission / regulatory plan) and technical regulatory documents (e.g., data H-Submissions, Innovation Task Force (ITF), Scientific Advice etc.) based on interpretation of both regulatory and scientific information
• Lead compliant commercial label delivery during pre-launch phase across major geographies (EU/US)
• 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.
• Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers
• 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.

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

• Bachelor's Degree or higher within the Sciences or equivalent experience
• 5+ years of similar industry experience
• Regulatory affairs experience
• Understanding of the drug development process
  

Additional Preferences:

• Understanding of the animal health industry

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