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Interested in joining a cause-driven, customer focused company dedicated to positively impacting the health of animals, people and the planet? Search our job listings below.
This position is responsible for management of Global Innovation with a focus on CMC Regulatory matters in projects at various stages of development specifically developing globally minded regulatory strategies for innovation projects, driving results in cross functional teams to execute on the strategy, leading discussions with regulatory authorities where appropriate, oversee submission preparation, complete the compilation and meet the reporting requirements for the registration/approval of new animal drug with global regulatory agencies, and successful transfer to lifecycle management processes.
This position will be a leader and decision maker that helps drive Innovation through the pipeline to registration and commercialization at the project, strategic and organizational level from a Global Regulatory CMC perspective. Leading through meaningful partnerships and expert knowledge to navigate risk and complexity is expected. Strong scientific background and demonstrated Global Regulatory CMC knowledge required. Expert in EU animal health pharmaceutical regulations preferred; additional experience with US FDA-CVM regulations desirable.
Functions, Duties, Task:
- Lead development and execution of CMC Regulatory strategy and tactics for complex innovation product submissions, with a diverse regulatory lens (e.g. EPA, CVM-FDA, MHRA, EMEA, TGA, ANVISA, etc.)
- Work with the CMC Regulatory Lead Team to help set and drive the strategy and efficiency of the Global Regulatory CMC department
- Anticipates and resolves key technical, operational, or business problems that impact function or geography and proactively works to communicate risks
- Influences complex regulatory, business, or technical issues within function and in partnership with global stakeholders across Elanco, including but not limited to Innovation Regulatory Affairs, Lifecycle Management Regulatory Affairs, Product Marketing and Manufacturing & Quality
- Project manage timely submission of pre-approval CMC documentation
- Coordinate assembly and / or generate documentation of submission-ready components to support original registrations.
- Collaborate with Post-Approval CMC team through transition phase for transfer of approved dossier for geo-expansion and lifecycle maintenance activities
- Review and approve regulatory CMC documents to ensure compliance
- Gain cross-functional approval for delivery of the documentation to Global Regulatory Affairs for worldwide use in regulatory submissions in first wave countries (e.g. US, EU, China, Brazil)
- Provide Regulatory Intelligence to support the operational and tactical regulatory CMC contribution and direction to Elanco product and project teams in support of global products throughout the life cycle.
- Lead regulatory authority interactions where necessary to drive development programs.
- Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
- Perform any other duties or serve in such other capacity as may be determined by Company management.
Additional Preferences:
- Additional language skills would be highly valued but not essential
- Desired, Masters or PhD in Physical, Chemical, or Life Sciences or Management
- GMP knowledge and experience, including quality assurance highly valued
- Knowledge and understanding of Quality by Design and Question based Review
Other Information:
- Personal Considerations: Domestic and international travel may be required
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
