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!
Your Role:
This role within the Global Regulatory Labeling Operations team is responsible for the control and coordination of regulatory label creation and change activities and for providing support to Affiliate Labeling Responsible Persons (ALRPs) for development of high quality, timely, cost-effective artwork.
Your Responsibilities:
- Serve as point of contact to the ALRPs to support coordination of regulatory label creation and change.
- Support the artwork development process for new products, changes in existing products, and marketing authorization transfers.
- Provide ongoing training and coaching to ALRPs to support the regulatory label creation and change process, to keep them informed of current information, and to share learnings from recent experiences.
- Coordinate with other functions (LCM, PPMQ, Supply, Art Studios) to support ALRPs with label change related queries.
- Liaise with ALRPs and LCM (Life Cycle Management) team to coordinate artwork development and change process timelines.
- Serve as point of contact for LCM team for any clarifications involving ALRPs.
- Initiate the artwork development or change process by ensuring the information needed to begin the process is accurate and the request is submitted to LCM in a timely manner.
- Manage communications between ALRPs and Global Regulatory, LCM, Quality and the Art Studios, ensuring all parties are aware of the status of changes, new requests, priorities and any issues as well as ensuring that the information required for the change is available and current.
- Work in alignment and maintain a positive business collaboration with labeling peers, ALRPs, LCM, PPMQ (Printed Packaging Material Quality) and Art Studios teams.
- Ensure all relevant process take place for ALRPs onboarding or exiting.
- Actively participate in GRLO team discussions to align and share information across the team.
- Generate and review metrics to identify and address issues and promote on-going improvements.
- Assess feasibility and remove barriers to enable successful artwork change or development in support of product launches and technical transfers.
- Support onboarding, coaching, training, and knowledge sharing with other RLAs.
- Proactively accept new challenges and search for innovative solutions.
- Other responsibilities as assigned to support regional affiliate or overall Global Regulatory Operations goals, including participation in special projects.
- Experienced and bringing in good project management skills.
What You Need to Succeed (minimum qualifications):
- Bachelor’s Degree.
- Fluent in English.
- Good computer literacy skills.
- +4 years experience in regulatory or related areas
What will give you a competitive edge (preferred qualifications):
- Prior regulatory, PPM or Labeling experience.
- Multi-lingual (ideally Portuguese and Spanish).
- Understanding and knowledge of GMP.
Additional Information:
- Hybrid work model: 3x in the office
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
