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.
YOUR TASKS AND RESPONSIBILITIES
Establish the strategy and manage the analytical aspects of technical small molecule brand maximization projects (product line extension or geo-expansion projects (particularly China but not only)) as part of Technical Development.
Ensure extension of existing product CMC registrations, providing efficient and effective support during dossier submissions, change control processes and troubleshooting
Establish effective collaboration and stakeholder management with global and local project management, technical project leads, quality, regulatory affairs, manufacturing site representatives and technical development scientists
Maintain up-to-date knowledge of global and country-specific regulatory requirements, guidelines (ICH, VICH), and technical developments.
Support preparation and review of technical reference documents/dossiers (e.g. CMC-part, VMF, product chemistry) for submission to obtain regulatory approvals.
Manage technical development relationships with third party contractors, manufacturers and development partners in support of brand maximization activities.
WHO YOU ARE
MSc., Engineer or PhD (preferred) in a scientific discipline (e.g. chemistry, pharmacy, etc.) with strong background in small molecule analytical development
Specialist knowledge and preferably several years experience of small molecule analytical development with a curiosity and willingness to develop in new areas
Experience of externalizing pharmaceutical development activities and collaborating with external partners (CROs, CDMOs, etc.)
Proven ability to collaborate with and to integrate different internal stakeholders e.g. technical development scientists, global and local project management, technical project leads, quality, regulatory affairs, manufacturing site representatives etc.
Organizational and personnel leadership skills
High ability to solve problems and to structure and simplify complex tasks
Very good communication and presentation skills (fluent in English, further 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
