2025 University Recruiting- Global Regulatory Affairs-CMC Co-Op

Job Description

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Animal Health Division can provide you with great development and a chance to see if we are the right company for your long-term goals

Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. GRA CMC PMs are also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.   

The Co-op will assist Product Managers (PM) in their role by taking on assigned projects that are part of the PMs’ daily activities while further developing their technical, organizational and communication skills interacting with cross-functional project teams.

Examples of projects and assignment areas include: 

• Assist with the system transition to Regulatory Information Management Systems (RIMS) SharePoint and s: drive to Archives and Alexx

• Fulfill document requests received via GRA Request Tracking Tool (RTT) to support PMs to focus on submission writing by liaising with cross-functional stakeholders

• Renewals & Geo-Expansions– GMP licenses, certificates, reports, etc.

• Backlog reduction; Metrics support

• Health Authority List of Questions (LoQs) trending

• Collect and organize LoQs

• Analyze and trend; develop metrics

• Regulatory Affairs Detailed Application Verification (DAV)- verification, maintenance

• Assist with other activities, e.g. new colleague onboarding/training scheduling 

• Optimize existing processes/ analyze for improvement opportunities

Required Education and Experience:

• Must be currently enrolled in a sophomore or junior level curriculum working toward a Bachelor’s degree, or pursuing a Master’s or higher degree in related sciences (engineering, biological sciences or chemistry) or regulatory affairs discipline

• Have superior analytical and technical competency as demonstrated by excellent academic record and work achievements.

• Have strong communication skills, personal character, and ethics

• Have working knowledge MS Office suite

Preferred Experience and Skills:

• Knowledge of Six Sigma principles

• Have leadership accomplishments achieved through direct leadership roles or leading by influence.

• Have demonstrated delivery results in a multi-functional, multi-disciplinary environment.

• Candidates should have a minimum GPA of 3.0

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the …