Associate, Regulatory Information System

Responsibilities:

• Accurately enter and maintain planned activities, handling of end-to-end activities which involves creation of events, applications, registrations, regulatory objectives, submissions, and tracking of activities for the RAP teams within the Veeva Vault RIM system.

• Responsible for the ownership of Document Request Process (DRP) in Veeva Vault RIM.

• Act as a key point of contact for system users, providing guidance and support on how to effectively enter and manage information in Veeva Vault RIM via scheduled calls and troubleshooting sessions.

• Ensure all information is configured and set up with technical precision within the Veeva Vault RIM platform to maintain global compliance standards.

• Contribute to a positive, high-energy working environment RAP Team, internal R&D, M&Q, fostering knowledge sharing and mutual support.

• Keep knowledge up to date regarding regulatory guidelines and requirements in major geographical regions.

• Provide training and mentorship to Veeva Vault RIM team members, as necessary.

• Responsible for the periodic generation and communication of Veeva Vault RIM KPI metrics.

Core Competencies:

• Working knowledge of regulatory affairs requirements in major geographies

• Basic working knowledge of Veeva Vault RIM and a strong general aptitude for managing complex software systems.

• Excellent interpersonal and communication skills, with the ability to explain technical concepts to non-technical users.

• Strong planning and organizational skills with a meticulous attention to detail.

• Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time

• Attention to detail, timeline driven

• Having expertise in the system audit will be an added advantage.

What You Need to Succeed (minimum qualifications):

• Degree in Science (DVM, MSc, B. Pharm/M. Pharm, Postgraduate in Vet Sciences etc.,)
• Minimum Experience:: 2 to 5 years of relevant experience in regulatory affairs, and/or data management.

What will give you a competitive edge (preferred qualifications):

• Ability to work independently and as part of a team.
• Ability to communicate effectively, verbally and in writing.
• Effective interpersonal skills.
• Create positive work environment that is aligned with company objectives.
• Work effectively and flexible within and across teams and external collaborations to achieve overall Elanco deliverables.

Additional Information:

• Travel: Not required
• Location: Bangalore

Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!