Senior Associate-R&D

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.

Position Description:

The Global Regulatory Data Manager will report into the Head of Regulatory Compliance and Transformation within Global Regulatory Operations. The position will drive and support transformational projects supporting Elanco’s Regulatory Information Management vision of increasing compliance and efficiency by connecting information & systems. The initial focus will be to support and prepare for the introduction of the Union Product database (UPD) in the European Union with the main focus on the mapping of Elanco SAP information to Vault RIM information.

The position will work closely together with the consultant Regulatory Information technology and the Elanco IT business partners to identify cross functional needs for regulatory information within Elanco and drive the execution of the strategy for system connectivity.

This position will also support any of the transformational activities or projects that are in scope for the Global Regulatory Compliance and Transformation team. This can either be related to IT or process/compliance topics or related to the regulatory business process metrics.

Functions, Duties, Tasks:

Key Responsibilities include, but are not limited to:

Support to regulatory transformational information management projects (60-80%)

• Support projects directly and/or indirectly related to set up and maintenance of regulatory/PV Datawarehouse and introduction of the UPD in the EU.
  • Drive the strategic (future state) direction of the Regulatory DWH; act as project manager in the coordination of subsequent regulatory projects.
  • Maintenance of SAP – vault RIM mapping data in the Data mapping solution (DMS) tool.
  • In close consultation with other internal stakeholders, drive the design and roll out of processes to supporting DWH and UPD upload.
  • Responsible for communication to stakeholders and identification of training needs associated with UPD readiness.
  • Responsible for the preparation of training materials and the execution of the training sessions.

• Drive and support transformational projects supporting Elanco’s regulatory information management vision of increasing compliance and efficiency by connecting information & systems.
  • Support and execute Regulatory information management strategy by participating as SME or serve as project manager in cross-functional transformational projects to allow for system or process improvements and data connectivity.
  • Engage cross-functionally to understand opportunities to streamline processes and/or increase compliance by data connectivity.
  • Identify data analytics opportunities that arise from data connectivity in the DWH.
  • Drive and execute the roll out of transformational projects and (GRO) activities which e.g. be related to Vault RIM or other regulatory processes and own communication to regulatory stakeholders and users to ensure adequate training to support roll out of transformational project
  • Responsibility to support assessment external (new) opportunities for shaping of Elanco’s future state Regulatory information technology landscape

General support of GRO activities and projects (20-40%)

• Support with the gathering and/or follow up of regulatory (business process) metrics.
• Drive and/or support, train and prepare the regulatory team for internal/external audits and help build compliance standard to meet with company quality framework
• Support to other teams in case of urgent resource needs or ad-hoc high priority GRO projects.
• 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.

Key Attributes:

• An innovative, true process “thinker”, with high affinity for IT tools/systems (e.g. SAP, Veeva Vault Platform, PV works)
• Excellent organizational, project management, and time management skills
• Excellent communicator, able to translate complex topics/information into easy-understandable
• Ability to think strategically across Elanco without losing attention to detail
• Understanding of the customer needs to drive effective solutions and demonstrated ability to negotiate solutions to complex technical challenges
• Ability to work in a virtual setting across different cultures and time zones
• Excellent communication skills (verbal and written in English)
• Strong collaboration, leadership and relationship management skills

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

• Bachelor’s Degree, preferably in a health-related or scientific field or a minimum of 5 years work experience in the pharmaceutical industry, drug development, or in regulatory affairs
• Knowledge of Elanco systems e.g. Veeva Vault platforms, SAP
• Preferably Lean six sigma qualification

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